Details for New Drug Application (NDA): 206597
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NDA 206597 describes HAILEY FE 1/20, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the HAILEY FE 1/20 profile page.
The generic ingredient in HAILEY FE 1/20 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 HAILEY FE 1/20 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 206597
| Tradename: | HAILEY FE 1/20 |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206597
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HAILEY FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 206597 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-419 | 68462-419-29 | 3 BLISTER PACK in 1 CARTON (68462-419-29) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;1MG | ||||
| Approval Date: | Nov 21, 2017 | TE: | AB | RLD: | No | ||||
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