Details for New Drug Application (NDA): 212918
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The generic ingredient in ATOVAQUONE is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 212918
Tradename: | ATOVAQUONE |
Applicant: | Bionpharma |
Ingredient: | atovaquone |
Patents: | 0 |
Suppliers and Packaging for NDA: 212918
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 212918 | ANDA | Golden State Medical Supply, Inc. | 51407-642 | 51407-642-87 | 1 BOTTLE in 1 CARTON (51407-642-87) / 210 mL in 1 BOTTLE |
ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 212918 | ANDA | Bionpharma Inc. | 69452-252 | 69452-252-87 | 1 BOTTLE in 1 CARTON (69452-252-87) / 210 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 750MG/5ML | ||||
Approval Date: | Mar 30, 2021 | TE: | AB | RLD: | No |
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