Details for New Drug Application (NDA): 210363
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The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Suppliers and Packaging for NDA: 210363
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | INJECTABLE;INJECTION | 210363 | ANDA | Natco Pharma USA LLC | 69339-136 | 69339-136-34 | 10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) |
DIAZEPAM | diazepam | INJECTABLE;INJECTION | 210363 | ANDA | REMEDYREPACK INC. | 70518-2358 | 70518-2358-1 | 10 SYRINGE, GLASS in 1 CARTON (70518-2358-1) / 2 mL in 1 SYRINGE, GLASS (70518-2358-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/2ML (5MG/ML) | ||||
Approval Date: | Mar 18, 2019 | TE: | AP | RLD: | No |
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