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Details for New Drug Application (NDA): 040133
NDA 040133 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Hikma Pharms, Ipca Labs Ltd, Mylan, Sandoz, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in eight NDAs. It is available from seventeen 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 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 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 |
| Therapeutic Class: | Antiparasitics |
| 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 | N | 0591-3041-05 |
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 040133 | ANDA | Actavis Pharma, Inc. | 0591-3041 | N | 0591-3041-01 |
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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