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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091232


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NDA 091232 describes TRI-LO-ESTARYLLA, which is a drug marketed by Xiromed and is included in one NDA. It is available from three suppliers. 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 091232
Tradename:TRI-LO-ESTARYLLA
Applicant:Xiromed
Ingredient:ethinyl estradiol; norgestimate
Patents:0
Suppliers and Packaging for NDA: 091232
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRI-LO-ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 091232 ANDA AvKARE 42291-565 42291-565-84 1 CARTON in 1 CARTON (42291-565-84) / 3 BLISTER PACK in 1 CARTON (42291-565-28) / 1 KIT in 1 BLISTER PACK
TRI-LO-ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 091232 ANDA Bryant Ranch Prepack 63629-2351 63629-2351-1 3 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACK

Profile 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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