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Details for New Drug Application (NDA): 076681

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NDA 076681 describes KIMIDESS, which is a drug marketed by Vintage Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the KIMIDESS profile page.

The generic ingredient in KIMIDESS is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 076681

Tradename:
KIMIDESS
Applicant:
Vintage Pharms
Ingredient:
desogestrel; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076681

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KIMIDESS
desogestrel; ethinyl estradiol
TABLET;ORAL-28 076681 ANDA Qualitest Pharmaceuticals 0603-7512 0603-7512-17 6 BLISTER PACK in 1 CARTON (0603-7512-17) > 1 KIT in 1 BLISTER PACK (0603-7512-01) * 21 TABLET, FILM COATED in 1 BLISTER PACK * 5 TABLET, FILM COATED in 1 BLISTER PACK
KIMIDESS
desogestrel; ethinyl estradiol
TABLET;ORAL-28 076681 ANDA Qualitest Pharmaceuticals 0603-7512 0603-7512-49 3 BLISTER PACK in 1 CARTON (0603-7512-49) > 1 KIT in 1 BLISTER PACK (0603-7512-01) * 21 TABLET, FILM COATED in 1 BLISTER PACK * 5 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG,N/A;0.02MG,0.01MG
Approval Date:Apr 30, 2015TE:ABRLD:No


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