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Generated: November 14, 2018

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Details for New Drug Application (NDA): 075840

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NDA 075840 describes CRYSELLE, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the CRYSELLE profile page.

The generic ingredient in CRYSELLE is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075840
Tradename:CRYSELLE
Applicant:Duramed Pharms Barr
Ingredient:ethinyl estradiol; norgestrel
Patents:0
Suppliers and Packaging for NDA: 075840
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRYSELLE ethinyl estradiol; norgestrel TABLET;ORAL-21 075840 ANDA Teva Pharmaceuticals USA, Inc. 0555-9049 0555-9049-58 6 POUCH in 1 CARTON (0555-9049-58) > 1 BLISTER PACK in 1 POUCH (0555-9049-79) > 1 KIT in 1 BLISTER PACK
CRYSELLE ethinyl estradiol; norgestrel TABLET;ORAL-21 075840 ANDA REMEDYREPACK INC. 70518-1214 70518-1214-0 6 POUCH in 1 CARTON (70518-1214-0) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.03MG;0.3MG
Approval Date:Nov 30, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.3MG
Approval Date:Nov 30, 2001TE:ABRLD:No

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