Details for New Drug Application (NDA): 076064
✉ Email this page to a colleague
NDA 076064 describes JUNEL FE 1.5/30, 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 1.5/30 profile page.
The generic ingredient in JUNEL 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 JUNEL 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 076064
| Tradename: | JUNEL FE 1.5/30 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076064
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JUNEL FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 076064 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9028 | 0555-9028-58 | 6 POUCH in 1 CARTON (0555-9028-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
| JUNEL FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 076064 | ANDA | Teva Women's Health LLC | 51285-128 | 51285-128-70 | 5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | Sep 18, 2003 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
