Details for New Drug Application (NDA): 076238
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The generic ingredient in BALZIVA-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 076238
Tradename: | BALZIVA-28 |
Applicant: | Barr |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 076238
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BALZIVA-28 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 076238 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9034 | 0555-9034-58 | 6 POUCH in 1 CARTON (0555-9034-58) / 1 BLISTER PACK in 1 POUCH (0555-9034-79) / 1 KIT in 1 BLISTER PACK |
BALZIVA-28 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 076238 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1725 | 53002-1725-1 | 1 KIT in 1 BLISTER PACK (53002-1725-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.4MG | ||||
Approval Date: | Apr 22, 2004 | TE: | AB | RLD: | No |
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