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ALBUTEROL SULFATE

ANDA

ALBUTEROL SULFATE | A074454 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

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.

Products (1)

#001 — EQ 2MG BASE/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Sep 25, 1995

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its corporate name from "Cosette" to "Cosette Pharms NC" in the Orange Book record for albuterol sulfate solution inhalation (NDA 074454).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the albuterol sulfate NDA 074454.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC