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 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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