Application 216049
- Type
- ANDA
- Sponsor
- SOMERSET THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 100MG/10ML (10MG/ML) | No | No |
| 002 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 200MG/10ML (20MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216049-001 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | |
| A216049-002 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216049-001 | AP |
| A216049-002 | AP |
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 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | 2024-09-19 | d06236e962d9… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216049-001 | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216049-002 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | 2024-09-19 | 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 | A216049-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216049-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-002 | AP | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-002 | AP | 1 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216049-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216049-002 | AP | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-001 | CGT | 2025-03-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216049-002 | CGT | 2025-03-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-001 | CGT | 2025-03-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216049-002 | CGT | 2025-03-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-001 | CGT | 2025-03-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216049-002 | CGT | 2025-03-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-001 | CGT | 2025-03-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216049-002 | CGT | 2025-03-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-001 | CGT | 2025-03-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216049-002 | CGT | 2025-03-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-001 | CGT | 2025-03-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216049-002 | CGT | 2025-03-30 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-001 | CGT | 2025-03-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216049-002 | CGT | 2025-03-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-001 | CGT | 2025-03-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216049-002 | CGT | 2025-03-30 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Henry Schein, Inc. | dd621bfa-ce48-4c27-b247-a6d885f70b72 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 216049 ANDA216049 |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Henry Schein, Inc. | 4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 216049 ANDA216049 |
| Nalbuphine hydrochloride | NALBUPHINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 292b0d0e-f222-d384-e063-6394a90acd44 | 2024-12-13 | Boxed warning, Adverse reactions | 216049 ANDA216049 |
| Nalbuphine hydrochloride | NALBUPHINE HYDROCHLORIDE | Somerset Therapeutics, LLC | d82dafac-cce7-445a-8127-2a10b6d947ca | 2024-09-26 | Boxed warning, Adverse reactions | 216049 ANDA216049 |