Details for New Drug Application (NDA): 204433
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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 204433
Tradename: | DIAZEPAM |
Applicant: | Chartwell Molecular |
Ingredient: | diazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204433
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | CONCENTRATE;ORAL | 204433 | ANDA | Chartwell RX, LLC | 62135-768 | 62135-768-43 | 30 mL in 1 BOTTLE (62135-768-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 5MG/ML | ||||
Approval Date: | Apr 14, 2014 | TE: | AA | RLD: | No |
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