Application 215609
- Type
- ANDA
- Sponsor
- ENCUBE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRETINOIN MICROSPHERE | TRETINOIN | GEL;TOPICAL | 0.08% | No | No |
| 002 | TRETINOIN MICROSPHERE | TRETINOIN | GEL;TOPICAL | 0.06% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215609-001 | TRETINOIN MICROSPHERE | TRETINOIN | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | |
| A215609-002 | TRETINOIN MICROSPHERE | TRETINOIN | 0.06% | GEL / TOPICAL | AB | 2026-04-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215609-001 | AB |
| A215609-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | 9b2671bbb829… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215609-001 | TRETINOIN MICROSPHERE | 0.08% | GEL / TOPICAL | AB | 2023-08-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215609-002 | TRETINOIN MICROSPHERE | 0.06% | GEL / TOPICAL | AB | 2026-04-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215609-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215609-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215609-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215609-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215609-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215609-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215609-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215609-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215609-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215609-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215609-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215609-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215609-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215609-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215609-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215609-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215609-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215609-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215609-001 | AB | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215609-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215609-002 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215609-001 | CGT | 2024-03-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215609-001 | CGT | 2024-03-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215609-001 | CGT | 2024-03-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215609-001 | CGT | 2024-03-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215609-001 | CGT | 2024-03-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215609-001 | CGT | 2024-03-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215609-001 | CGT | 2024-03-06 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215609-001 | CGT | 2024-03-06 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215609-001 | CGT | 2024-03-06 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215609-001 | CGT | 2024-03-06 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215609-001 | CGT | 2024-03-06 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215609-001 | CGT | 2024-03-06 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215609-001 | CGT | 2024-03-06 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215609-001 | CGT | 2024-03-06 | 9b2671bbb829… |
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 | Encube Ethicals, Inc. | 57558405-42fa-40bb-a61c-48e030d976de | 2026-04-16 | Warnings, Adverse reactions | 215609 ANDA215609 |
| Tretinoin | TRETINOIN | Bryant Ranch Prepack | 2b58cf56-e713-4cdd-8b4e-e6651ef76650 | 2026-03-04 | Warnings, Adverse reactions | 215609 ANDA215609 |
| Tretinoin (Microsphere) | TRETINOIN | Mayne Pharma | ed2103ee-c9d5-4b3d-b525-318cf67be050 | 2024-10-28 | Warnings, Adverse reactions | 215609 ANDA215609 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75398 | ORIG | 2023-09-12 |