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Generated: June 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021490

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NDA 021490 describes FEMCON FE, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FEMCON FE profile page.

The generic ingredient in FEMCON FE is ethinyl estradiol; norethindrone. 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; norethindrone profile page.
Summary for 021490
Tradename:FEMCON FE
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone
Patents:1
Suppliers and Packaging for NDA: 021490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490 NDA Allergan, Inc. 0023-5970 0023-5970-05 5 BLISTER PACK in 1 CARTON (0023-5970-05) > 1 KIT in 1 BLISTER PACK
FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490 NDA AUTHORIZED GENERIC Lupin Pharmaceuticals, Inc. 68180-897 68180-897-13 5 POUCH in 1 CARTON (68180-897-13) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength0.035MG;0.4MG
Approval Date:Nov 14, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 6, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

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