Details for New Drug Application (NDA): 074253
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The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 074253
Tradename: | BUSPIRONE HYDROCHLORIDE |
Applicant: | Impax Labs Inc |
Ingredient: | buspirone hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 074253
Suppliers and Packaging for NDA: 074253
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 074253 | ANDA | Proficient Rx LP | 63187-221 | 63187-221-30 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-221-30) |
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 074253 | ANDA | Proficient Rx LP | 63187-221 | 63187-221-60 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-221-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 28, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 28, 2001 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Mar 13, 2002 | TE: | AB | RLD: | No |
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