Details for New Drug Application (NDA): 202330
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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 202330
Tradename: | BUSPIRONE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | buspirone hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202330
Suppliers and Packaging for NDA: 202330
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 202330 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8434 | 0615-8434-39 | 30 TABLET in 1 BLISTER PACK (0615-8434-39) |
BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 202330 | ANDA | Strides Pharma Inc. | 42543-741 | 42543-741-06 | 100 TABLET in 1 BOTTLE (42543-741-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 25, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 25, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 25, 2014 | TE: | AB | RLD: | No |
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