Details for New Drug Application (NDA): 207769
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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 207769
Tradename: | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | dutasteride; tamsulosin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207769
Mechanism of Action | 5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 207769
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 207769 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-640 | 68382-640-06 | 30 CAPSULE in 1 BOTTLE (68382-640-06) |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 207769 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-640 | 68382-640-16 | 90 CAPSULE in 1 BOTTLE (68382-640-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG;0.4MG | ||||
Approval Date: | May 24, 2018 | TE: | AB | RLD: | No |
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