Details for New Drug Application (NDA): 090248
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The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 090248
Tradename: | ALPRAZOLAM |
Applicant: | Strides Pharma |
Ingredient: | alprazolam |
Patents: | 0 |
Suppliers and Packaging for NDA: 090248
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET;ORAL | 090248 | ANDA | Strides Pharma Science Limited | 64380-276 | 64380-276-01 | 100 TABLET in 1 BOTTLE (64380-276-01) |
ALPRAZOLAM | alprazolam | TABLET;ORAL | 090248 | ANDA | Strides Pharma Science Limited | 64380-276 | 64380-276-02 | 500 TABLET in 1 BOTTLE (64380-276-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Sep 17, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Sep 17, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Sep 17, 2010 | TE: | AB | RLD: | No |
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