Details for New Drug Application (NDA): 209031
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NDA 209031 describes HAILEY FE 1.5/30, which is a drug marketed by Glenmark Speclt and is included in one NDA. It is available from two suppliers. Additional details are available on the HAILEY FE 1.5/30 profile page.
The generic ingredient in HAILEY FE 1.5/30 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 1.5/30 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 209031
| Tradename: | HAILEY FE 1.5/30 |
| Applicant: | Glenmark Speclt |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209031
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HAILEY FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 209031 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1812 | 53002-1812-1 | 1 POUCH in 1 CARTON (53002-1812-1) / 1 KIT in 1 POUCH |
| HAILEY FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 209031 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1812 | 53002-1812-3 | 3 POUCH in 1 CARTON (53002-1812-3) / 1 KIT in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | Jun 5, 2018 | TE: | AB | RLD: | No | ||||
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