Details for New Drug Application (NDA): 210692
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NDA 210692 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 210692
| Tradename: | ATOVAQUONE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | atovaquone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 210692 | ANDA | PAI Holdings, LLC | 0121-0898 | 0121-0898-18 | 3 TRAY in 1 CASE (0121-0898-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05) |
| ATOVAQUONE | atovaquone | SUSPENSION;ORAL | 210692 | ANDA | PAI Holdings, LLC | 0121-0898 | 0121-0898-42 | 7 TRAY in 1 CASE (0121-0898-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 750MG/5ML | ||||
| Approval Date: | Oct 11, 2018 | TE: | AB | RLD: | No | ||||
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