Details for New Drug Application (NDA): 077705
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NDA 077705 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, and Teva, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 077705
| Tradename: | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE |
| Applicant: | Mylan |
| Ingredient: | fosinopril sodium; hydrochlorothiazide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG;12.5MG | ||||
| Approval Date: | Aug 14, 2006 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG;12.5MG | ||||
| Approval Date: | Aug 14, 2006 | TE: | RLD: | No | |||||
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