Details for New Drug Application (NDA): 214745
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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 214745
Tradename: | DIAZEPAM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | diazepam |
Patents: | 0 |
Suppliers and Packaging for NDA: 214745
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | INJECTABLE;INJECTION | 214745 | ANDA | Fresenius Kabi USA, LLC | 76045-204 | 76045-204-20 | 24 SYRINGE, GLASS in 1 CARTON (76045-204-20) / 2 mL in 1 SYRINGE, GLASS (76045-204-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/2ML (5MG/ML) | ||||
Approval Date: | Nov 10, 2022 | TE: | AP | RLD: | No |
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