Application 016921
- Type
- NDA
- Sponsor
- VALEANT INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RETIN-A | TRETINOIN | SOLUTION;TOPICAL | 0.05% | Yes | No |
| 002 | RETIN-A | TRETINOIN | SWAB;TOPICAL | 0.05% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016921-001 | RETIN-A | TRETINOIN | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | ||
| N016921-002 | RETIN-A | TRETINOIN | 0.05% | SWAB / TOPICAL | Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016921-001 | RETIN-A | 0.05% | SOLUTION / TOPICAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016921-002 | RETIN-A | 0.05% | SWAB / TOPICAL | Approved before 1982 | 74a2ff9319b5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tretinoin | TRETINOIN | Oceanside Pharmaceuticals | d3c528d2-429d-4f37-9ebf-eee8b9fd3050 | 2025-09-30 | Warnings, Adverse reactions | TRETINOIN |
| TRETINOIN | TRETINOIN | Encube Ethicals, Inc. | b61f6b02-6171-4da8-94eb-bcd4808dd918 | 2025-09-16 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Alembic Pharmaceuticals Limited | 4e96fb71-14f4-4789-91af-ba94b0879162 | 2025-09-16 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NuCare Pharmaceuticals,Inc. | 3deccf35-67ad-9cbc-e063-6394a90a7ee9 | 2025-09-03 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NuCare Pharmaceuticals,Inc. | 3ded762b-5fe6-c5ef-e063-6294a90ad602 | 2025-09-03 | Warnings, Adverse reactions | TRETINOIN |
| Retin-A MICRO | TRETINOIN | Bausch Health US LLC | 08ab7e0c-1437-455f-815c-98904d96a289 | 2025-09-01 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | A-S Medication Solutions | da206984-4ded-4d5c-8a23-323920466a5f | 2025-07-23 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NORTHSTAR RX LLC | 2e508351-eca3-427e-8d16-e840a84db0f5 | 2025-07-09 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NORTHSTAR RX LLC | de3e7308-1212-4727-b541-568a84dac48a | 2025-07-09 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Sun Pharmaceutical Industries, Inc. | 9e964be5-8d67-46a8-888e-0351f9113f68 | 2025-07-02 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Sun Pharmaceutical Industries, Inc. | 2b0c8ee4-83a5-48f1-809a-9716131f7290 | 2025-07-02 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Aurobindo Pharma Limited | dea325b5-3cb8-4ffb-84e9-782f0e3f6b0e | 2025-06-19 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Aurobindo Pharma Limited | f64e45d7-bbc0-4da4-9ccb-e3941f22fdbe | 2025-06-18 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NuCare Pharmaceuticals,Inc. | 373dd14d-061a-4408-e063-6394a90abf95 | 2025-06-10 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Sun Pharmaceutical Industries, Inc. | 2a31b13b-5cc8-4f6a-b364-872f6a478025 | 2025-05-27 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NORTHSTAR RX LLC | c0212b19-0676-4546-bc5d-682c089e7b7d | 2025-05-27 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Alembic Pharmaceuticals Limited | 7845d60d-7c4c-4854-a417-6d3ea86a710f | 2025-04-25 | Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | Preferred Pharmaceuticals Inc. | fda88f47-21b3-4678-ab21-befb03035730 | 2025-04-11 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NuCare Pharmaceuticals, Inc. | 31d2794a-ca4b-246a-e063-6394a90a1954 | 2025-04-02 | Warnings, Adverse reactions | TRETINOIN |
| Tretinoin | TRETINOIN | NuCare Pharmaceuticals, Inc. | 31d2cd00-e534-6755-e063-6394a90ab8bb | 2025-04-02 | Warnings, Adverse reactions | TRETINOIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.