Details for New Drug Application (NDA): 210510
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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 210510
Tradename: | ATOVAQUONE |
Applicant: | Abhai Llc |
Ingredient: | atovaquone |
Patents: | 0 |
Suppliers and Packaging for NDA: 210510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 210510 | ANDA | KVK-Tech, Inc. | 10702-223 | 10702-223-21 | 1 BOTTLE, PLASTIC in 1 CARTON (10702-223-21) / 210 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 750MG/5ML | ||||
Approval Date: | May 31, 2019 | TE: | AB | RLD: | No |
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