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-three 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 |
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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