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Details for New Drug Application (NDA): 090293

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NDA 090293 describes GILDESS 24 FE, 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 GILDESS 24 FE profile page.

The generic ingredient in GILDESS 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 090293

Tradename:
GILDESS 24 FE
Applicant:
Vintage Pharms
Ingredient:
ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090293

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GILDESS 24 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL 090293 ANDA Qualitest Pharmaceuticals 0603-7610 0603-7610-17 6 BLISTER PACK in 1 CARTON (0603-7610-17) > 1 KIT in 1 BLISTER PACK (0603-7610-01)
GILDESS 24 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL 090293 ANDA Qualitest Pharmaceuticals 0603-7610 0603-7610-49 3 BLISTER PACK in 1 CARTON (0603-7610-49) > 1 KIT in 1 BLISTER PACK (0603-7610-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG
Approval Date:Dec 1, 2014TE:ABRLD:No


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