Details for New Drug Application (NDA): 203038
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NDA 203038 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Pharms Ltd, Xiromed, Dr Reddys Labs Sa, Amneal Pharms, and Apotex, and is included in twenty-three NDAs. It is available from four suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.
The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 203038
| Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 203038
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 203038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203038 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-656 | 68462-656-29 | 3 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203038 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-656 | 68462-656-90 | 90 TABLET in 1 BOTTLE (68462-656-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0025MG;0.5MG | ||||
| Approval Date: | Apr 2, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
| Approval Date: | Apr 2, 2015 | TE: | AB | RLD: | No | ||||
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