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Details for New Drug Application (NDA): 076238

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NDA 076238 describes BALZIVA-28, 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 BALZIVA-28 profile page.

The generic ingredient in BALZIVA-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 076238

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076238

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; norethindrone
TABLET;ORAL-28 076238 ANDA Teva Pharmaceuticals USA, Inc. 0093-3305 0093-3305-16 6 POUCH in 1 CARTON (0093-3305-16) > 1 BLISTER PACK in 1 POUCH (0093-3305-28) > 1 KIT in 1 BLISTER PACK
ethinyl estradiol; norethindrone
TABLET;ORAL-28 076238 ANDA Warner Chilcott (US), LLC 0430-0580 0430-0580-14 72 CARTON in 1 CASE (0430-0580-14) > 5 CELLO PACK in 1 CARTON > 1 BLISTER PACK in 1 CELLO PACK > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Apr 22, 2004TE:ABRLD:No

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