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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213099
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/04/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE;EQ 0.5% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020869 THEA PHARMA
COSOPT PF DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 202667 THEA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077847 AKORN
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203058 AKORN
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 213099 ALEMBIC PHARMS LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090037 BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207629 EUGIA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207630 EUGIA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205295 FDC LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 215520 GLAND PHARMA LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202054 INDOCO
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204777 MICRO LABS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 215936 MICRO LABS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078749 SANDOZ
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090604 SANDOZ INC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207523 SOMERSET
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078704 TEVA PHARMS
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