Details for New Drug Application (NDA): 202975
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NDA 202975 describes DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma, Endo Operations, and Zydus Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE profile page.
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.
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 202975
| Tradename: | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | dutasteride; tamsulosin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.5MG;0.4MG | ||||
| Approval Date: | Nov 20, 2015 | TE: | RLD: | No | |||||
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