Application 216097
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No |
| 003 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 25MG | No | No |
| 004 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No |
| 005 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 35MG | No | No |
| 006 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216097-001 | ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE / ORAL | 2025-10-07 | ||
| A216097-002 | ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE / ORAL | 2025-10-07 | ||
| A216097-003 | ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE / ORAL | 2025-10-07 | ||
| A216097-004 | ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE / ORAL | 2025-10-07 | ||
| A216097-005 | ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE / ORAL | 2025-10-07 | ||
| A216097-006 | ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE / ORAL | 2025-10-07 |
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 | A216097-001 | ISOTRETINOIN | 10MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216097-002 | ISOTRETINOIN | 20MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216097-003 | ISOTRETINOIN | 25MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216097-004 | ISOTRETINOIN | 30MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216097-005 | ISOTRETINOIN | 35MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216097-006 | ISOTRETINOIN | 40MG | CAPSULE / ORAL | 2025-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-001 | ISOTRETINOIN | 10MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-002 | ISOTRETINOIN | 20MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-003 | ISOTRETINOIN | 25MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-004 | ISOTRETINOIN | 30MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-005 | ISOTRETINOIN | 35MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216097-006 | ISOTRETINOIN | 40MG | CAPSULE / ORAL | 2025-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216097-001 | ISOTRETINOIN | 10MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-002 | ISOTRETINOIN | 20MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-003 | ISOTRETINOIN | 25MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-004 | ISOTRETINOIN | 30MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-005 | ISOTRETINOIN | 35MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-006 | ISOTRETINOIN | 40MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-001 | ISOTRETINOIN | 10MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-002 | ISOTRETINOIN | 20MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-003 | ISOTRETINOIN | 25MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-004 | ISOTRETINOIN | 30MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-005 | ISOTRETINOIN | 35MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-006 | ISOTRETINOIN | 40MG | CAPSULE / ORAL | AB2 | 2025-10-07 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-001 | ISOTRETINOIN | 10MG | CAPSULE / ORAL | 2025-10-07 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-002 | ISOTRETINOIN | 20MG | CAPSULE / ORAL | 2025-10-07 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-003 | ISOTRETINOIN | 25MG | CAPSULE / ORAL | 2025-10-07 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-004 | ISOTRETINOIN | 30MG | CAPSULE / ORAL | 2025-10-07 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-005 | ISOTRETINOIN | 35MG | CAPSULE / ORAL | 2025-10-07 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216097-006 | ISOTRETINOIN | 40MG | CAPSULE / ORAL | 2025-10-07 | 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 | A216097-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-005 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216097-006 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216097-006 | AB2 | 1 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Isotretinoin | ISOTRETINOIN | Amneal Pharmaceuticals NY LLC | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 216097 ANDA216097 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.