Details for New Drug Application (NDA): 213342
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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 213342
Tradename: | HYDROXYCHLOROQUINE SULFATE |
Applicant: | Accord Hlthcare |
Ingredient: | hydroxychloroquine sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 213342
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-485 | 16729-485-01 | 100 TABLET in 1 BOTTLE (16729-485-01) |
HYDROXYCHLOROQUINE SULFATE | hydroxychloroquine sulfate | TABLET;ORAL | 213342 | ANDA | Accord Healthcare, Inc., | 16729-485 | 16729-485-16 | 500 TABLET in 1 BOTTLE (16729-485-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 7, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 18, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Aug 18, 2021 | TE: | AB | RLD: | No |
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