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) |
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 NDC: | 0603-7606-15 |
Package Description: | 6 BLISTER PACK in 1 CARTON (0603-7606-15) > 21 TABLET, FILM COATED in 1 BLISTER PACK (0603-7606-02) |
NDC Code | 0603-7606-15 |
Proprietary Name | Gildess 1.5/30 |
Package Description | 6 BLISTER PACK in 1 CARTON (0603-7606-15) > 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] |