Details for New Drug Application (NDA): 216049
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NDA 216049 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc, and is included in seventeen NDAs. It is available from five suppliers. Additional details are available on the NALBUPHINE HYDROCHLORIDE profile page.
The generic ingredient in NALBUPHINE HYDROCHLORIDE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
The generic ingredient in NALBUPHINE HYDROCHLORIDE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
Summary for 216049
| Tradename: | NALBUPHINE HYDROCHLORIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | nalbuphine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216049
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 216049
Suppliers and Packaging for NDA: 216049
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 216049 | ANDA | Somerset Therapeutics, LLC | 70069-661 | 70069-661-10 | 1 VIAL, MULTI-DOSE in 1 CARTON (70069-661-10) / 10 mL in 1 VIAL, MULTI-DOSE |
| NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 216049 | ANDA | Somerset Therapeutics, LLC | 70069-662 | 70069-662-10 | 1 VIAL, MULTI-DOSE in 1 CARTON (70069-662-10) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Sep 19, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 30, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Sep 19, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 30, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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