Details for New Drug Application (NDA): 090931
✉ Email this page to a colleague
The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-two 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 |
Formulation / Manufacturing: | see details |
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 | NorthStar RxLLC | 16714-713 | 16714-713-01 | 100 CAPSULE in 1 BOTTLE (16714-713-01) |
TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 090931 | ANDA | NorthStar RxLLC | 16714-713 | 16714-713-02 | 500 CAPSULE in 1 BOTTLE (16714-713-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.4MG | ||||
Approval Date: | Jul 15, 2010 | TE: | AB | RLD: | No |
Complete Access Available with Subscription