Details for New Drug Application (NDA): 216007
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NDA 216007 describes NALMEFENE HYDROCHLORIDE, which is a drug marketed by Chengdu Shuode and Purdue Pharma Lp and is included in two NDAs. It is available from two suppliers. Additional details are available on the NALMEFENE HYDROCHLORIDE profile page.
The generic ingredient in NALMEFENE HYDROCHLORIDE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
The generic ingredient in NALMEFENE HYDROCHLORIDE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
Summary for 216007
| Tradename: | NALMEFENE HYDROCHLORIDE |
| Applicant: | Chengdu Shuode |
| Ingredient: | nalmefene hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216007
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 216007
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007 | ANDA | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-101 | 82432-101-01 | 1 VIAL, GLASS in 1 CARTON (82432-101-01) / 1 mL in 1 VIAL, GLASS |
| NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007 | ANDA | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-102 | 82432-102-02 | 1 VIAL, GLASS in 1 CARTON (82432-102-02) / 2 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | ||||
| Approval Date: | Nov 15, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Nov 15, 2023 | TE: | AP | RLD: | No | ||||
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