Details for New Drug Application (NDA): 078801
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NDA 078801 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-two 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-three 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-three suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 078801
| Tradename: | TAMSULOSIN HYDROCHLORIDE |
| Applicant: | Synthon Pharms |
| Ingredient: | tamsulosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078801
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 078801
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 078801 | ANDA | Synthon Pharmaceuticals, Inc. | 63672-0021 | 63672-0021-9 | 20000 CAPSULE in 1 DRUM (63672-0021-9) |
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 078801 | ANDA | EXELAN PHARMACEUTICALS, INC. | 76282-744 | 76282-744-05 | 500 CAPSULE in 1 BOTTLE (76282-744-05) |
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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