Details for New Drug Application (NDA): 070325
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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 070325
Tradename: | DIAZEPAM |
Applicant: | Mylan |
Ingredient: | diazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 070325
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | TABLET;ORAL | 070325 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0271 | 0378-0271-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0271-01) |
DIAZEPAM | diazepam | TABLET;ORAL | 070325 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0271 | 0378-0271-05 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0271-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 4, 1985 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 4, 1985 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 4, 1985 | TE: | AB | RLD: | No |
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