Details for New Drug Application (NDA): 204582
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The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 204582
Tradename: | BUSPIRONE HYDROCHLORIDE |
Applicant: | Heritage Pharma |
Ingredient: | buspirone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 204582
Suppliers and Packaging for NDA: 204582
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 204582 | ANDA | Major Pharmaceuticals | 0904-7121 | 0904-7121-61 | 100 BLISTER PACK in 1 CARTON (0904-7121-61) / 1 TABLET in 1 BLISTER PACK |
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 204582 | ANDA | Major Pharmaceuticals | 0904-7122 | 0904-7122-61 | 100 BLISTER PACK in 1 CARTON (0904-7122-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 18, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 18, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Sep 18, 2015 | TE: | AB | RLD: | No |
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