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Details for New Drug Application (NDA): 075808

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NDA 075808 describes TRI-SPRINTEC, which is a drug marketed by Barr and is included in one NDA. It is available from seven suppliers. Additional details are available on the TRI-SPRINTEC profile page.

The generic ingredient in TRI-SPRINTEC 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: 075808

ethinyl estradiol; norgestimate

Suppliers and Packaging for NDA: 075808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; norgestimate
TABLET;ORAL-28 075808 ANDA Teva Pharmaceuticals USA, Inc. 0555-9018 0555-9018-58 6 POUCH in 1 CARTON (0555-9018-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK
ethinyl estradiol; norgestimate
TABLET;ORAL-28 075808 ANDA Rebel Distributors Corp 21695-770 21695-770-01 1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Dec 29, 2003TE:ABRLD:No

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