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Details for New Drug Application (NDA): 040133
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NDA 040133 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Alkaloida Zrt, Amneal Pharms Co, Hikma Pharms, Invatech, Ipca Labs Ltd, Laurus Labs Ltd, Lupin Ltd, Mylan, Sandoz, Teva Pharms, Twi Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from twenty-four suppliers. Additional details are available on the HYDROXYCHLOROQUINE SULFATE profile page.
The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 040133
| Tradename: | HYDROXYCHLOROQUINE SULFATE |
| Applicant: | Watson Labs |
| Ingredient: | hydroxychloroquine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 040133 | ANDA | Actavis Pharma, Inc. | 0591-3041 | 0591-3041-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-3041-01) |
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 040133 | ANDA | Actavis Pharma, Inc. | 0591-3041 | 0591-3041-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0591-3041-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 30, 1995 | TE: | AB | RLD: | No | ||||
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