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Details for New Drug Application (NDA): 091232

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NDA 091232 describes TRI-LO-ESTARYLLA, which is a drug marketed by Sandoz Inc and is included in one NDA. It is available from one supplier. Additional details are available on the TRI-LO-ESTARYLLA profile page.

The generic ingredient in TRI-LO-ESTARYLLA is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for NDA: 091232

Sandoz Inc
ethinyl estradiol; norgestimate

Suppliers and Packaging for NDA: 091232

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; norgestimate
TABLET;ORAL-28 091232 ANDA Sandoz Inc 0781-4062 0781-4062-15 3 BLISTER PACK in 1 CARTON (0781-4062-15) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date:Jun 29, 2015TE:ABRLD:No

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