Details for New Drug Application (NDA): 076380
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The generic ingredient in JUNEL 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 076380
Tradename: | JUNEL 1/20 |
Applicant: | Barr |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Pharmacology for NDA: 076380
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 076380
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
JUNEL 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076380 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9025 | 0555-9025-42 | 3 POUCH in 1 CARTON (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
JUNEL 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076380 | ANDA | Teva Women's Health LLC | 51285-131 | 51285-131-97 | 5 POUCH in 1 CARTON (51285-131-97) / 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 | 0.02MG;1MG | ||||
Approval Date: | May 30, 2003 | TE: | AB | RLD: | No |
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