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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212942
Company: ALEMBIC PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB No Yes
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212942Orig1s000ltr.pdf

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 212942 ALEMBIC PHARMS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 215733 DR REDDYS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 214645 GLAND PHARMA LTD
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020963 SANDOZ INC
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.25% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020330 BAUSCH AND LOMB INC

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 212942 ALEMBIC PHARMS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription No AB 215733 DR REDDYS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020963 SANDOZ INC
TIMOPTIC-XE TIMOLOL MALEATE EQ 0.5% BASE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC Prescription Yes AB 020330 BAUSCH AND LOMB INC
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