Details for New Drug Application (NDA): 040657
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NDA 040657 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-eight 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. Thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 040657
| Tradename: | HYDROXYCHLOROQUINE SULFATE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | hydroxychloroquine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 040657
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 040657 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8459 | 0615-8459-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8459-39) |
| HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 040657 | ANDA | Northstar Rx LLC. | 16714-110 | 16714-110-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-110-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 21, 2007 | TE: | AB | RLD: | No | ||||
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