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TIMOLOL MALEATE

ANDA

TIMOLOL MALEATE | A212942 | ALEMBIC PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TIMOLOL MALEATE(TE code: AB)

API Supply Chain13 active DMFs5 inactive

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

OLON SPATIMOLOL MALEATE

DMF 66441986

PCASTIMOLOL MALEATE

DMF 69831987

TAPI NL BVTIMOLOL MALEATE

DMF 72641987

FDC LTDTIMOLOL MALEATE USP

DMF 98391992

EXCELLA GMBH AND CO KGTIMOLOL MALEATE

DMF 155162001

SYN-TECH CHEM AND PHARM CO LTDTIMOLOL MALEATE USP

DMF 230092009

CENTAUR PHARMACEUTICALS PVT LTDTIMOLOL MALEATE USP

DMF 236302010

PCASTIMOLOL MALEATE (7125)

DMF 293422015

FAREVA LA VALLEETIMOLOL MALEATE

DMF 320642019

SYN-TECH CHEM AND PHARM CO LTDTIMOLOL MALEATE (TMM)

DMF 364282022

MICRO LABS LTDTIMOLOL MALEATE USP

DMF 372282022

GLOBAL CALCIUM PRIVATE LTDTIMOLOL MALEATE USP

DMF 396352024

C-SQUARED PHARMA LTDTIMOLOL MALEATE

DMF 428162025

SUMITOMO CHEMICAL CO LTDInactiveTIMOLOL MALEATE

DMF 82261989

SUZHOU NUMBER 1 PHARMACEUTICAL FACTORYInactiveTIMOLOL MALEATE USP

DMF 86491990

VIALE FULVIO TESTIInactiveTIMOLOL MALEATE

DMF 109001994

DEGUSSA AG WERK RADEBEULInactiveTIMOLOL MALEATE

DMF 122341996

SIFAVITOR SPAInactiveTIMOLOL MALEATE

DMF 147502000

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.25% BASE

0 patents0 exclusivities▴

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Approved: Oct 22, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 0.5% BASE

0 patents0 exclusivities▾

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Approved: Oct 22, 2020