Details for New Drug Application (NDA): 201691
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NDA 201691 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Appco, Aurobindo Pharma Usa, Chartwell Rx, Creekwood Pharms, Hikma Pharms, Ipca Labs Ltd, Laurus, Sandoz, Senores Pharms, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from twenty-five 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 201691
| Tradename: | HYDROXYCHLOROQUINE SULFATE |
| Applicant: | Alkaloida Zrt |
| Ingredient: | hydroxychloroquine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201691
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 201691 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-761 | 57664-761-13 | 500 TABLET in 1 BOTTLE (57664-761-13) |
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 201691 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-761 | 57664-761-88 | 100 TABLET in 1 BOTTLE (57664-761-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 8, 2018 | TE: | AB | RLD: | No | ||||
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