Details for New Drug Application (NDA): 218450
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The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 218450
Tradename: | DIAZEPAM |
Applicant: | Alembic |
Ingredient: | diazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 218450
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | INJECTABLE;INJECTION | 218450 | ANDA | Alembic Pharmaceuticals Limited | 46708-811 | 46708-811-20 | 10 SYRINGE, GLASS in 1 CARTON (46708-811-20) / 2 mL in 1 SYRINGE, GLASS (46708-811-02) |
DIAZEPAM | diazepam | INJECTABLE;INJECTION | 218450 | ANDA | Alembic Pharmaceuticals Inc. | 62332-811 | 62332-811-20 | 10 SYRINGE, GLASS in 1 CARTON (62332-811-20) / 2 mL in 1 SYRINGE, GLASS (62332-811-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/2ML (5MG/ML) | ||||
Approval Date: | Apr 25, 2024 | TE: | AP | RLD: | No |
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