Details for New Drug Application (NDA): 208829
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NDA 208829 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rising, Rubicon, Strides Pharma, Teva, Unichem, and Zydus Pharms, and is included in twenty-one NDAs. It is available from forty-three suppliers. Additional details are available on the BUSPIRONE HYDROCHLORIDE profile page.
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.
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 208829
| Tradename: | BUSPIRONE HYDROCHLORIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | buspirone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208829
Suppliers and Packaging for NDA: 208829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 208829 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1115 | 69238-1115-1 | 100 TABLET in 1 BOTTLE (69238-1115-1) |
| BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 208829 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1115 | 69238-1115-5 | 500 TABLET in 1 BOTTLE (69238-1115-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 24, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | May 24, 2017 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 24, 2017 | TE: | RLD: | No | |||||
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