Details for New Drug Application (NDA): 076381
✉ Email this page to a colleague
NDA 076381 describes JUNEL 1.5/30, which is a drug marketed by Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the JUNEL 1.5/30 profile page.
The generic ingredient in JUNEL 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 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 076381
| Tradename: | JUNEL 1.5/30 |
| Applicant: | Barr |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 076381
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 076381
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JUNEL 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076381 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9027 | 0555-9027-42 | 3 POUCH in 1 CARTON (0555-9027-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
| JUNEL 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076381 | ANDA | Teva Women's Health LLC | 51285-127 | 51285-127-97 | 5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;1.5MG | ||||
| Approval Date: | May 30, 2003 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
