Details for New Drug Application (NDA): 009768
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NDA 009768 describes PLAQUENIL, which is a drug marketed by Advanz Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the PLAQUENIL profile page.
The generic ingredient in PLAQUENIL 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 PLAQUENIL 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 009768
| Tradename: | PLAQUENIL |
| Applicant: | Advanz Pharma |
| Ingredient: | hydroxychloroquine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 009768
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLAQUENIL | hydroxychloroquine sulfate | TABLET;ORAL | 009768 | NDA | Advanz Pharma (US) Corp. | 59212-562 | 59212-562-10 | 100 TABLET in 1 BOTTLE (59212-562-10) |
| PLAQUENIL | hydroxychloroquine sulfate | TABLET;ORAL | 009768 | NDA | Advanz Pharma (US) Corp. | 59212-562 | 59212-562-11 | 100 TABLET in 1 BOTTLE (59212-562-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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