Viewing data from:

BRIMONIDINE TARTRATE

ANDA

BRIMONIDINE TARTRATE | A076260 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ALPHAGAN P(TE code: AT)

API Supply Chain12 active DMFs1 inactive

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

FARMAK ASBRIMONIDINE TARTRATE

DMF 155852001

MEDICHEM SABRIMONIDINE TARTRATE

DMF 156012001

PIRAMAL PHARMA LTDBRIMONIDINE TARTRATE

DMF 175882004

FDC LTDBRIMONIDINE TARTRATE USP

DMF 208552007

INDOCO REMEDIES LTDBRIMONIDINE TARTRATE USP

DMF 221662008

SYMED LABS LTDBRIMONIDINE TARTRATE

DMF 222302008

C-SQUARED PHARMA LTDBRIMONIDINE TARTRATE

DMF 225102009

CENTAUR PHARMACEUTICALS PVT LTDBRIMONIDINE TARTRATE USP

DMF 238802010

SIEGFRIED GRAFTON INCBRIMONIDINE TARTRATE

DMF 242132010

UNICHEM LABORATORIES LTDBRIMONIDINE TARTRATE

DMF 250512011

MICRO LABS LTDBRIMONIDINE TARTRATE USP

DMF 343622019

MAITHRI DRUGS PRIVATE LTDBRIMONIDINE TARTRATE USP

DMF 365952021

LUPIN LTDInactiveBRIMONIDINE TARTRATE

DMF 252592011

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

Products (1)

#001 — 0.2%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 28, 2003

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Bausch and Lomb's trade name for brimonidine tartrate (NDA 076260) reflects a legal entity name change from "Bausch and Lomb" to "Bausch and Lomb Inc" in FDA records.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb Pharmaceuticals Inc updated its registered applicant name to Bausch and Lomb Inc for brimonidine tartrate NDA 076260.

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC