Details for New Drug Application (NDA): 207833
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NDA 207833 describes ATOVAQUONE, which is a drug marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Glenmark Pharms Ltd, and Mylan, and is included in eleven NDAs. It is available from eighteen suppliers. Additional details are available on the ATOVAQUONE profile page.
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.
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 207833
| Tradename: | ATOVAQUONE |
| Applicant: | Chartwell Rx |
| Ingredient: | atovaquone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 207833 | ANDA | Chartwell RX, LLC | 62135-528 | 62135-528-09 | 210 mL in 1 BOTTLE (62135-528-09) |
| ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 207833 | ANDA | Chartwell RX, LLC | 62135-528 | 62135-528-24 | 2 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 750MG/5ML | ||||
| Approval Date: | Apr 28, 2017 | TE: | AB | RLD: | No | ||||
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