Details for New Drug Application (NDA): 071136
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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 071136
Tradename: | DIAZEPAM |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | diazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071136
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | TABLET;ORAL | 071136 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-276 | 43353-276-15 | 15 TABLET in 1 BOTTLE, PLASTIC (43353-276-15) |
DIAZEPAM | diazepam | TABLET;ORAL | 071136 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-276 | 43353-276-30 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-276-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 3, 1987 | TE: | AB | RLD: | No |
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