Details for New Drug Application (NDA): 217843
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The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 217843
Tradename: | DIAZEPAM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | diazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217843
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | diazepam | TABLET;ORAL | 217843 | ANDA | Aurobindo Pharma Limited | 59651-652 | 59651-652-01 | 100 TABLET in 1 BOTTLE (59651-652-01) |
DIAZEPAM | diazepam | TABLET;ORAL | 217843 | ANDA | Aurobindo Pharma Limited | 59651-652 | 59651-652-05 | 500 TABLET in 1 BOTTLE (59651-652-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 14, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 14, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 14, 2023 | TE: | AB | RLD: | No |
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