Details for New Drug Application (NDA): 009768
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NDA 009768 describes PLAQUENIL, which is a drug marketed by Concordia 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. Twenty-eight 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 009768
| Tradename: | PLAQUENIL |
| Applicant: | Concordia |
| 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 AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-051 | 43353-051-09 | 9000 TABLET in 1 BOTTLE (43353-051-09) |
| PLAQUENIL | hydroxychloroquine sulfate | TABLET;ORAL | 009768 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-051 | 43353-051-53 | 60 TABLET in 1 BOTTLE (43353-051-53) |
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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