Details for New Drug Application (NDA): 203346
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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 203346
Tradename: | ALPRAZOLAM |
Applicant: | Aurobindo Pharma |
Ingredient: | alprazolam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALPRAZOLAM | alprazolam | TABLET;ORAL | 203346 | ANDA | Medsource Pharmaceuticals | 45865-257 | 45865-257-30 | 30 TABLET in 1 BOTTLE (45865-257-30) |
ALPRAZOLAM | alprazolam | TABLET;ORAL | 203346 | ANDA | American Health Packaging | 60687-377 | 60687-377-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-377-01) / 1 TABLET in 1 BLISTER PACK (60687-377-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jul 31, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jul 31, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jul 31, 2015 | TE: | AB | RLD: | No |
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