Application 217468
- Type
- ANDA
- Sponsor
- NAVINTA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 2.5MG/0.5ML (5MG/ML) | No | No |
| 002 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 10MG/2ML (5MG/ML) | No | No |
| 003 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 20MG/4ML (5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217468-001 | DIAZEPAM | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | |
| A217468-002 | DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | |
| A217468-003 | DIAZEPAM | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217468-001 | AB |
| A217468-002 | AB |
| A217468-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217468-001 | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217468-002 | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217468-003 | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217468-001 | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217468-002 | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217468-003 | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-001 | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-002 | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-003 | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-001 | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-002 | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-003 | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-001 | DIAZEPAM | 2.5MG/0.5ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-002 | DIAZEPAM | 10MG/2ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-003 | DIAZEPAM | 20MG/4ML (5MG/ML) | GEL / RECTAL | AB | 2025-11-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217468-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217468-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217468-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217468-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217468-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217468-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217468-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217468-003 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217468-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Diazepam | DIAZEPAM | Navinta LLC | b5b17a28-2cab-4c0d-8f9d-7b224e4d0989 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 217468 ANDA217468 |
| Diazepam | DIAZEPAM | Zydus Pharmaceuticals USA Inc. | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 217468 ANDA217468 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84744 | ORIG | 2026-01-13 |