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Gildess 1.5/30 - 0603-7606-48 - (norethindrone acetate and ethinyl estradiol)

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Drug Information of Gildess 1.5/30

Product NDC: 0603-7606
Proprietary Name: Gildess 1.5/30
Non Proprietary Name: norethindrone acetate and ethinyl estradiol
Active Ingredient(s): .03; 1.5    mg/1; mg/1 & nbsp;   norethindrone acetate and ethinyl estradiol
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Gildess 1.5/30

Product NDC: 0603-7606
Labeler Name: Qualitest Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077075
Marketing Category: ANDA
Start Marketing Date: 20120724

Package Information of Gildess 1.5/30

Package NDC: 0603-7606-48
Package Description: 3 BLISTER PACK in 1 CARTON (0603-7606-48) > 21 TABLET, FILM COATED in 1 BLISTER PACK (0603-7606-02)

NDC Information of Gildess 1.5/30

NDC Code 0603-7606-48
Proprietary Name Gildess 1.5/30
Package Description 3 BLISTER PACK in 1 CARTON (0603-7606-48) > 21 TABLET, FILM COATED in 1 BLISTER PACK (0603-7606-02)
Product NDC 0603-7606
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name norethindrone acetate and ethinyl estradiol
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120724
Marketing Category Name ANDA
Labeler Name Qualitest Pharmaceuticals
Substance Name ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Strength Number .03; 1.5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]

Complete Information of Gildess 1.5/30


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