Application 083247
- Type
- ANDA
- Sponsor
- OAK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEMBUTAL | PENTOBARBITAL SODIUM | SUPPOSITORY;RECTAL | 30MG | No | No |
| 002 | NEMBUTAL | PENTOBARBITAL SODIUM | SUPPOSITORY;RECTAL | 60MG | No | No |
| 003 | NEMBUTAL | PENTOBARBITAL SODIUM | SUPPOSITORY;RECTAL | 120MG | No | No |
| 004 | NEMBUTAL | PENTOBARBITAL SODIUM | SUPPOSITORY;RECTAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083247-001 | NEMBUTAL | PENTOBARBITAL SODIUM | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | ||
| A083247-002 | NEMBUTAL | PENTOBARBITAL SODIUM | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | ||
| A083247-003 | NEMBUTAL | PENTOBARBITAL SODIUM | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | ||
| A083247-004 | NEMBUTAL | PENTOBARBITAL SODIUM | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083247-001 | NEMBUTAL | 30MG | SUPPOSITORY / RECTAL | 1982-01-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083247-002 | NEMBUTAL | 60MG | SUPPOSITORY / RECTAL | 1982-01-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083247-003 | NEMBUTAL | 120MG | SUPPOSITORY / RECTAL | 1982-01-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083247-004 | NEMBUTAL | 200MG | SUPPOSITORY / RECTAL | 1982-01-25 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Pentobarbital Sodium | PENTOBARBITAL SODIUM | Hikma Pharmaceuticals USA Inc. | d375b92a-baa1-4d63-9ad1-1467dcfde7d5 | 2024-03-08 | Warnings, Adverse reactions | PENTOBARBITAL SODIUM |
| pentobarbital sodium | PENTOBARBITAL SODIUM | Sagent Pharmaceuticals | e9f4b344-b092-4eec-b49d-d8cfe8ebc05d | 2017-06-30 | Warnings, Adverse reactions | PENTOBARBITAL SODIUM |