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 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 |
Formulation / Manufacturing: | see details |
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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