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Details for New Drug Application (NDA): 021323

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NDA 021323 describes LEXAPRO, which is a drug marketed by Forest Labs and is included in two NDAs. It is available from fourteen suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEXAPRO profile page.

The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-five drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. There are eighteen tentative approvals for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 021323

Tradename:
LEXAPRO
Applicant:
Forest Labs
Ingredient:
escitalopram oxalate
Patents:2
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for NDA: 021323

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXAPRO
escitalopram oxalate
TABLET;ORAL 021323 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-3855 0378-3855-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3855-77)
LEXAPRO
escitalopram oxalate
TABLET;ORAL 021323 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-3856 0378-3856-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3856-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 14, 2002TE:ABRLD:No
Patent:6,916,941*PEDPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:7,420,069*PEDPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 14, 2002TE:ABRLD:No
Patent:6,916,941*PEDPatent Expiration:Feb 12, 2023Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021323

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
LEXAPRO
escitalopram oxalate
TABLET;ORAL021323-001Aug 14, 2002RE34712*PED► subscribe
Forest Labs
LEXAPRO
escitalopram oxalate
TABLET;ORAL021323-003Aug 14, 2002RE34712*PED► subscribe
Forest Labs
LEXAPRO
escitalopram oxalate
TABLET;ORAL021323-002Aug 14, 2002RE34712*PED► subscribe
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