Details for New Drug Application (NDA): 074896
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NDA 074896 describes CAPTOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Cosette, Ivax Sub Teva Pharms, Rising, Strides Pharma, and Watson Labs, and is included in five NDAs. It is available from one supplier. Additional details are available on the CAPTOPRIL AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in CAPTOPRIL AND HYDROCHLOROTHIAZIDE is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.
The generic ingredient in CAPTOPRIL AND HYDROCHLOROTHIAZIDE is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.
Summary for 074896
| Tradename: | CAPTOPRIL AND HYDROCHLOROTHIAZIDE |
| Applicant: | Rising |
| Ingredient: | captopril; hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 074896
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 074896
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | captopril; hydrochlorothiazide | TABLET;ORAL | 074896 | ANDA | Rising Pharma Holdings, Inc. | 16571-827 | 16571-827-09 | 90 TABLET in 1 BOTTLE (16571-827-09) |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | captopril; hydrochlorothiazide | TABLET;ORAL | 074896 | ANDA | Rising Pharma Holdings, Inc. | 16571-828 | 16571-828-09 | 90 TABLET in 1 BOTTLE (16571-828-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;15MG | ||||
| Approval Date: | Dec 29, 1997 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;25MG | ||||
| Approval Date: | Dec 29, 1997 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;25MG | ||||
| Approval Date: | Dec 29, 1997 | TE: | RLD: | No | |||||
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