Details for New Drug Application (NDA): 074461
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NDA 074461 describes INDAPAMIDE, which is a drug marketed by Actavis Elizabeth, Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Rising, Teva, and Watson Labs, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the INDAPAMIDE profile page.
The generic ingredient in INDAPAMIDE is indapamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the indapamide profile page.
The generic ingredient in INDAPAMIDE is indapamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the indapamide profile page.
Summary for 074461
| Tradename: | INDAPAMIDE |
| Applicant: | Rising |
| Ingredient: | indapamide |
| Patents: | 0 |
Pharmacology for NDA: 074461
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 074461
Suppliers and Packaging for NDA: 074461
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDAPAMIDE | indapamide | TABLET;ORAL | 074461 | ANDA | Rising Pharma Holdings, Inc. | 16571-875 | 16571-875-01 | 100 TABLET in 1 BOTTLE (16571-875-01) |
| INDAPAMIDE | indapamide | TABLET;ORAL | 074461 | ANDA | Rising Pharma Holdings, Inc. | 16571-876 | 16571-876-01 | 100 TABLET in 1 BOTTLE (16571-876-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Mar 27, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
| Approval Date: | Mar 26, 1997 | TE: | AB | RLD: | No | ||||
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