Details for New Drug Application (NDA): 078225
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NDA 078225 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs, Macleods Pharms Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. It is available from forty-three suppliers. Additional details are available on the TAMSULOSIN HYDROCHLORIDE profile page.
The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 078225
| Tradename: | TAMSULOSIN HYDROCHLORIDE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | tamsulosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078225
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 078225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 078225 | ANDA | Bryant Ranch Prepack | 63629-4346 | 63629-4346-1 | 30 CAPSULE in 1 BOTTLE (63629-4346-1) |
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 078225 | ANDA | Bryant Ranch Prepack | 63629-4346 | 63629-4346-2 | 100 CAPSULE in 1 BOTTLE (63629-4346-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.4MG | ||||
| Approval Date: | Apr 27, 2010 | TE: | AB | RLD: | No | ||||
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