Details for New Drug Application (NDA): 075521
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The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 075521
Tradename: | BUSPIRONE HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | buspirone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 075521
Suppliers and Packaging for NDA: 075521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 075521 | ANDA | REMEDYREPACK INC. | 70518-3428 | 70518-3428-0 | 30 TABLET in 1 BLISTER PACK (70518-3428-0) |
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 075521 | ANDA | REMEDYREPACK INC. | 70518-3446 | 70518-3446-0 | 30 TABLET in 1 BLISTER PACK (70518-3446-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 5, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 5, 2002 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Apr 5, 2002 | TE: | AB | RLD: | No |
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