Details for New Drug Application (NDA): 208972
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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 208972
Tradename: | BUSPIRONE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | buspirone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 208972
Suppliers and Packaging for NDA: 208972
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 208972 | ANDA | Epic Pharma, LLC | 42806-082 | 42806-082-01 | 100 TABLET in 1 BOTTLE (42806-082-01) |
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 208972 | ANDA | Epic Pharma, LLC | 42806-082 | 42806-082-05 | 500 TABLET in 1 BOTTLE (42806-082-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 16, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Apr 16, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 16, 2019 | TE: | AB | RLD: | No |
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