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ALBUTEROL SULFATE

ANDA

ALBUTEROL SULFATE | A203760 | PADAGIS US LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: PROAIR HFA(TE code: AB2)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Teva Branded Pharmaceutical Products R&D Inc. et al v. Perrigo Pharmaceuticals Co. et al 1:2013cv01441 4 patentsANDA 203760albuterol sulfate	D. Del.	2013-08-16	Terminated 2014-06-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain12 active DMFs1 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDALBUTEROL SULFATE USP

DMF 68851987

FDC LTDALBUTEROL SULFATE USP

DMF 78091988

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGALBUTEROL SULFATE (UNMICRONIZED)

DMF 142581999

NEULAND LABORATORIES LTDALBUTEROL SULFATE USP

DMF 163712003

CIPLA LTDALBUTEROL SULFATE USP

DMF 166782003

MELODY HEALTHCARE PVT LTDALBUTEROL SULFATE USP

DMF 265622012

LUSOCHIMICA SPAALBUTEROL SULFATE

DMF 289972015

SUPRIYA LIFESCIENCE LTDALBUTEROL SULFATE USP

DMF 307082016

PEARL THERAPEUTICS INCALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBO

DMF 319952017

OLON SPAALBUTEROL SULFATE

DMF 341752020

LUPIN LTDALBUTEROL SULFATE

DMF 396822024

VAMSI LABS LTDALBUTEROL SULFATE USP

DMF 425932025

NEULAND LABORATORIES LTDInactiveALBUTEROL SULFATE

DMF 102541993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 17, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH

AB2

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Feb 24, 2020

No patent or exclusivity listings for this strength.