Details for New Drug Application (NDA): 074505
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NDA 074505 describes CAPTOPRIL, which is a drug marketed by Ajanta Pharma Ltd, Andas 5 Holding, Apothecon, Aurobindo Pharma Usa, Changzhou Pharm, Chartwell Rx, Corepharma, Cosette, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Oxford Pharms, Prinston Inc, Purepac Pharm, Sandoz, Seton Pharms, Strides Pharma, Teva, Watson Labs, Wockhardt, Ivax Sub Teva Pharms, and Rising, and is included in thirty-one NDAs. It is available from thirteen suppliers. Additional details are available on the CAPTOPRIL profile page.
The generic ingredient in CAPTOPRIL 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 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 074505
| Tradename: | CAPTOPRIL |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | captopril |
| Patents: | 0 |
Pharmacology for NDA: 074505
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 074505
Suppliers and Packaging for NDA: 074505
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | captopril | TABLET;ORAL | 074505 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1171 | 0143-1171-01 | 100 TABLET in 1 BOTTLE (0143-1171-01) |
| CAPTOPRIL | captopril | TABLET;ORAL | 074505 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1171 | 0143-1171-10 | 1000 TABLET in 1 BOTTLE (0143-1171-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Feb 13, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 13, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 13, 1996 | TE: | AB | RLD: | No | ||||
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