Details for New Drug Application (NDA): 214581
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NDA 214581 describes SOVUNA, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the SOVUNA profile page.
The generic ingredient in SOVUNA 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 SOVUNA 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 214581
| Tradename: | SOVUNA |
| Applicant: | Novitium Pharma |
| Ingredient: | hydroxychloroquine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214581
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOVUNA | hydroxychloroquine sulfate | TABLET;ORAL | 214581 | NDA | ANI Pharmaceuticals, Inc. | 70954-804 | 70954-804-10 | 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10) |
| SOVUNA | hydroxychloroquine sulfate | TABLET;ORAL | 214581 | NDA | ANI Pharmaceuticals, Inc. | 70954-804 | 70954-804-20 | 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 14, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 14, 2022 | TE: | RLD: | Yes | |||||
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