Details for New Drug Application (NDA): 091163
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NDA 091163 describes FOSINOPRIL SODIUM, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Ani Pharms, Aurobindo Pharma, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from seven suppliers. Additional details are available on the FOSINOPRIL SODIUM profile page.
The generic ingredient in FOSINOPRIL SODIUM 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 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 091163
| Tradename: | FOSINOPRIL SODIUM |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | fosinopril sodium |
| Patents: | 0 |
Pharmacology for NDA: 091163
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 091163
Suppliers and Packaging for NDA: 091163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSINOPRIL SODIUM | fosinopril sodium | TABLET;ORAL | 091163 | ANDA | Aurobindo Pharma Limited | 65862-471 | 65862-471-30 | 30 TABLET in 1 BOTTLE (65862-471-30) |
| FOSINOPRIL SODIUM | fosinopril sodium | TABLET;ORAL | 091163 | ANDA | Aurobindo Pharma Limited | 65862-471 | 65862-471-90 | 90 TABLET in 1 BOTTLE (65862-471-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 30, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 30, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Mar 30, 2011 | TE: | AB | RLD: | No | ||||
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