Details for New Drug Application (NDA): 202509
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The generic ingredient in DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 202509
Tradename: | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE |
Applicant: | Endo Operations |
Ingredient: | dutasteride; tamsulosin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202509
Mechanism of Action | 5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 202509
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 202509 | ANDA | Endo USA, Inc. | 10370-280 | 10370-280-09 | 90 CAPSULE in 1 BOTTLE (10370-280-09) |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 202509 | ANDA | Endo USA, Inc. | 10370-280 | 10370-280-11 | 30 CAPSULE in 1 BOTTLE (10370-280-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG;0.4MG | ||||
Approval Date: | Feb 26, 2014 | TE: | AB | RLD: | No |
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