| Daunorubicin | CA Health Canada | — | Marketed in Canada as DAUNORUBICIN INJECTABLE SOLUTION (DIN 02501481) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 2, 2026 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE INJECTION (DIN 02539209) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 31, 2024 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as VYXEOS (DIN 02515490) under ATC L01XY01 CYTARABINE AND DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 6, 2021 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE FOR INJECTION (DIN 02231420) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | Mar 4, 1998 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as DAUNOXOME LIPOSOMAL - IV 2MG/ML, 50MG/VIAL (DIN 02218046) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Sep 21, 2001 | Sep 22, 1997 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as CERUBIDINE (DIN 01926683) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 31, 1971 | health-canada-dpd |
| Daunorubicin | CA Health Canada | — | Marketed in Canada as DAUNORUBICIN INJECTABLE SOLUTION (DIN 02501473) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Daunorubicin | EU EMA | — | Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). | approved | Aug 23, 2018 | ema |
| Daunorubicin | US FDA | — | Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults. | approved | Jan 30, 1998 | openfda |
| Tretinoin | CA Health Canada | — | Marketed in Canada as JAMP TRETINOIN (DIN 02520036) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 29, 2022 | health-canada-dpd |
| Tretinoin | CA Health Canada | — | Marketed in Canada as VESANOID (DIN 02145839) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 31, 1995 | health-canada-dpd |
| Tretinoin | US FDA | — | ALTRENO ® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1) | approved | Aug 23, 2018 | openfda |
| Tretinoin | US FDA | — | Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 ) | approved | Jul 26, 2007 | openfda |
| Tretinoin | US FDA | — | Efficacy supplement 2002-05-10 (see label) | approved | May 10, 2002 | openfda |
| Tretinoin | US FDA | Malignant Skin Neoplasm | Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time. | approved | Aug 31, 2000 | openfda |
| Tretinoin | US FDA | — | (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established. • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS ). Clinical Trials Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10-unit scale and changes from that baseline rating were categorized as follows: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings ma… |
| Tretinoin | US FDA | — | RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1) | approved | Feb 7, 1997 | openfda |
| Tretinoin | US FDA | — | Tretinoin Cream, USP is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established. | approved | Jan 14, 1997 | openfda |
| Tretinoin | US FDA | — | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Sep 16, 1988 | openfda |
| Tretinoin | US FDA | — | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Oct 17, 1978 | openfda |
| Tretinoin | US FDA | — | RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Apr 18, 1975 | openfda |
| Tretinoin | US FDA | — | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Jul 19, 1974 | openfda |
| Tretinoin | US FDA | — | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Jan 26, 1973 | openfda |
| Valproic Acid | US FDA | — | Epilepsy Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions ( 5.1 ) for statement regarding fatal hepatic dysfunction. 1.2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 ), Use in Specific Populations ( 8.1 ), and Patient Counseling Information ( 17 )] . For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications ( 4 )] . | approved | Jul 1, 1986 | openfda |