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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 200293


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NDA 200293 describes ARFORMOTEROL TARTRATE, which is a drug marketed by Alembic, Cipla, Glenmark Pharms Ltd, Lupin, Mankind Pharma, Ritedose Corp, Slate Run Pharma, Slayback Pharma Llc, Sun Pharm, and Teva Pharms Usa, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the ARFORMOTEROL TARTRATE profile page.

The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.
Summary for 200293
Tradename:ARFORMOTEROL TARTRATE
Applicant:Teva Pharms Usa
Ingredient:arformoterol tartrate
Patents:0
Pharmacology for NDA: 200293
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 200293
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 200293 ANDA Teva Pharmaceuticals USA, Inc. 0093-5955 0093-5955-06 12 POUCH in 1 CARTON (0093-5955-06) / 5 AMPULE in 1 POUCH (0093-5955-45) / 2 mL in 1 AMPULE (0093-5955-19)
ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 200293 ANDA Teva Pharmaceuticals USA, Inc. 0093-5955 0093-5955-56 30 POUCH in 1 CARTON (0093-5955-56) / 1 AMPULE in 1 POUCH (0093-5955-11) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.015MG BASE/2ML
Approval Date:Nov 9, 2021TE:ANRLD:No

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