Active ingredient
Tretinoin
83 finished FDA listings contain Tretinoin as their only active ingredient; 8 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TRETINOIN
- Dosage forms
- Capsule, Cream, Gel, Lotion
- Routes
- Oral, Topical
- Manufacturers / labelers
- 28
- Strengths listed
- .05 g/100g · .1 mg/g · .2 mg/g · .25 mg/g · .4 mg/g · .5 mg/g · .6 mg/g · .8 mg/g · 1 mg/g · 10 mg/1
- Brand names in FDA listings
- Altreno, Atralin, Renova, Retin-A, Retin-A Micro, Tretinoin (Microsphere), Tretinoin Cream
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10753
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017340 | BAUSCH | 1973-01-26 | 3 |
| NDA 017522 | BAUSCH | 1974-07-19 | 3 |
| NDA 017579 | VALEANT INTL | 1975-04-18 | 3 |
| NDA 017955 | BAUSCH | 1978-10-17 | 3 |
| NDA 019049 | BAUSCH | 1988-09-16 | 3 |
| NDA 020404 | MYLAN PHARMS INC | 1997-01-14 | 2 |
| NDA 020475 | BAUSCH | 1997-02-07 | 7 |
| ANDA 075265 | PADAGIS US | 1998-12-24 | 3 |
| ANDA 075213 | PADAGIS US | 1998-12-24 | 2 |
| ANDA 075264 | PADAGIS US | 1998-12-24 | 5 |
| ANDA 075529 | PADAGIS US | 2000-02-22 | 1 |
| NDA 021108 | VALEANT PHARMS NORTH | 2000-08-31 | 1 |
| ANDA 075589 | PADAGIS US | 2002-06-11 | 1 |
| NDA 022070 | DOW PHARM | 2007-07-26 | 3 |
| ANDA 201687 | PH HEALTH | 2012-10-24 | 4 |
| ANDA 207955 | MYLAN | 2015-08-13 | 1 |
| ANDA 208279 | GLENMARK PHARMS LTD | 2016-12-23 | 1 |
| NDA 209353 | DOW PHARM | 2018-08-23 | 1 |
| ANDA 211645 | SUN PHARMA CANADA | 2019-01-22 | 5 |
| ANDA 211644 | SUN PHARMA CANADA | 2019-01-25 | 4 |
| ANDA 215713 | SUN PHARMA CANADA | 2023-01-05 | 7 |
| ANDA 215609 | ENCUBE | 2023-08-22 | 4 |
| ANDA 218561 | ZYDUS LIFESCIENCES | 2024-04-25 | 2 |
| ANDA 217804 | ALEMBIC | 2024-04-29 | 2 |
| ANDA 218246 | AUROBINDO PHARMA LTD | 2025-01-13 | 1 |
| ANDA 218245 | AUROBINDO PHARMA LTD | 2025-02-27 | 1 |
| ANDA 217587 | ENCUBE | 2025-03-03 | 1 |
| ANDA 217588 | ENCUBE | 2025-03-03 | 1 |
| ANDA 217831 | ENCUBE | 2025-07-10 | 1 |
| ANDA 218399 | ALEMBIC | 2025-08-14 | 2 |
| ANDA 217833 | ENCUBE | 2026-02-10 | 1 |
| ANDA 217832 | ENCUBE | 2026-03-25 | 1 |
| ANDA 217497 | AMNEAL | 2026-05-14 | 1 |
| ANDA 214590 | ALEMBIC | 2026-06-11 | 2 |
Official labeling on DailyMed
- TRETINOIN CAPSULE [PAR HEALTH USA, LLC] · version 20 · 2026-08-24
- TRETINOIN CREAM [REDPHARM DRUG] · version 1 · 2026-08-03
- TRETINOIN GEL TRETINOIN CREAM [PADAGIS US LLC] · version 19 · 2026-07-29
- TRETINOIN CREAM [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2026-07-02
- TRETINOIN CREAM [ALEMBIC PHARMACEUTICALS INC.] · version 1 · 2026-06-29
- TRETINOIN CAPSULE [MAJOR PHARMACEUTICALS] · version 9 · 2026-06-08
- TRETINOIN GEL [AMNEAL PHARMACEUTICALS NY LLC] · version 7 · 2026-05-20
- TRETINOIN GEL [ENCUBE ETHICALS, INC.] · version 5 · 2026-04-17
- TRETINOIN CREAM [REMEDYREPACK INC.] · version 8 · 2026-04-08
- TRETINOIN CREAM [ENCUBE ETHICALS, INC.] · version 4 · 2026-04-03
- TRETINOIN GEL [BRYANT RANCH PREPACK] · version 101 · 2026-03-06
- RENOVA (TRETINOIN) CREAM [BAUSCH HEALTH US LLC] · version 14 · 2026-02-26
Showing the 12 most recent of 59 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.