Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216049
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | AP | No | No |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
NALBUPHINE HYDROCHLORIDE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; 100MG/10ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 070915 | HOSPIRA |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 216049 | SOMERSET THERAPS LLC |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; 200MG/10ML (20MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 070918 | HOSPIRA |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 216049 | SOMERSET THERAPS LLC |