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Last Updated: August 4, 2021

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Details for New Drug Application (NDA): 202689

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NDA 202689 describes VOLNEA, which is a drug marketed by Xiromed and is included in one NDA. It is available from two suppliers. Additional details are available on the VOLNEA profile page.

The generic ingredient in VOLNEA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 202689
Ingredient:desogestrel; ethinyl estradiol
Suppliers and Packaging for NDA: 202689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOLNEA desogestrel; ethinyl estradiol TABLET;ORAL-28 202689 ANDA Bryant Ranch Prepack 63629-2449 63629-2449-1 3 BLISTER PACK in 1 CARTON (63629-2449-1) > 1 KIT in 1 BLISTER PACK
VOLNEA desogestrel; ethinyl estradiol TABLET;ORAL-28 202689 ANDA Xiromed, LLC. 70700-122 70700-122-85 3 CARTON in 1 CARTON (70700-122-85) > 1 BLISTER PACK in 1 CARTON (70700-122-84) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG,N/A;0.02MG,0.01MG
Approval Date:Sep 9, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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