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Details for New Drug Application (NDA): 076081
NDA 076081 describes JUNEL FE 1/20, which is a drug marketed by Barr and is included in one NDA. It is available from three suppliers. Additional details are available on the JUNEL FE 1/20 profile page.
The generic ingredient in JUNEL FE 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in JUNEL FE 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 076081
| Tradename: | JUNEL FE 1/20 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JUNEL FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 076081 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9026 | N | 0555-9026-58 |
| JUNEL FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 076081 | ANDA | Teva Women's Health, Inc. | 51285-125 | N | 51285-125-70 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;1MG | ||||
| Approval Date: | Sep 18, 2003 | TE: | AB | RLD: | No | ||||
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