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-three 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 |
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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