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Details for New Drug Application (NDA): 076675

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NDA 076675 describes EMOQUETTE, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the EMOQUETTE profile page.

The generic ingredient in EMOQUETTE 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: 076675

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

Suppliers and Packaging for NDA: 076675

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMOQUETTE
desogestrel; ethinyl estradiol
TABLET;ORAL-28 076675 ANDA Qualitest Pharmaceuticals 0603-7540 0603-7540-17 6 BLISTER PACK in 1 CARTON (0603-7540-17) > 1 KIT in 1 BLISTER PACK (0603-7540-01)
EMOQUETTE
desogestrel; ethinyl estradiol
TABLET;ORAL-28 076675 ANDA Qualitest Pharmaceuticals 0603-7540 0603-7540-49 3 BLISTER PACK in 1 CARTON (0603-7540-49) > 1 KIT in 1 BLISTER PACK (0603-7540-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Feb 25, 2011TE:ABRLD:No


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