Details for New Drug Application (NDA): 090931
✉ Email this page to a colleague
NDA 090931 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs, Macleods Pharms Ltd, Ph Health, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Synthon Bv, Teva Pharms, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from thirty-nine 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. Thirty-nine 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 090931
| Tradename: | TAMSULOSIN HYDROCHLORIDE |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | tamsulosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090931
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 090931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 090931 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-019 | 43353-019-30 | 30 CAPSULE in 1 BOTTLE (43353-019-30) |
| TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 090931 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-019 | 43353-019-53 | 60 CAPSULE in 1 BOTTLE (43353-019-53) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.4MG | ||||
| Approval Date: | Jul 15, 2010 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
