Details for New Drug Application (NDA): 090871
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The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 090871
Tradename: | ALPRAZOLAM |
Applicant: | Aurobindo Pharma |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090871
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 090871 | ANDA | Proficient Rx LP | 63187-445 | 63187-445-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-30) |
ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 090871 | ANDA | Proficient Rx LP | 63187-445 | 63187-445-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-445-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jun 7, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1MG | ||||
Approval Date: | Jun 7, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
Approval Date: | Jun 7, 2011 | TE: | AB | RLD: | No |
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