Details for New Drug Application (NDA): 212809
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NDA 212809 describes CAPTOPRIL, which is a drug marketed by Aiping Pharm Inc, Ajanta Pharma Ltd, Andas 5 Holding, Apothecon, Aurobindo Pharma Usa, 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 Intl, Teva, Watson Labs, Wockhardt Bio Ag, 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 212809
| Tradename: | CAPTOPRIL |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | captopril |
| Patents: | 0 |
Pharmacology for NDA: 212809
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 212809
Suppliers and Packaging for NDA: 212809
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | captopril | TABLET;ORAL | 212809 | ANDA | Major Pharmaceuticals | 0904-7105 | 0904-7105-61 | 100 BLISTER PACK in 1 CARTON (0904-7105-61) / 1 TABLET in 1 BLISTER PACK |
| CAPTOPRIL | captopril | TABLET;ORAL | 212809 | ANDA | Major Pharmaceuticals | 0904-7106 | 0904-7106-61 | 100 BLISTER PACK in 1 CARTON (0904-7106-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Dec 13, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 13, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 13, 2019 | TE: | AB | RLD: | No | ||||
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