Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077846
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% 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
10/28/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077846s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2015 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

01/25/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/06/2009 SUPPL-1 Labeling

Label is not available on this site.

DORZOLAMIDE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 212639 ALEMBIC PHARMS LTD
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090143 BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205294 FDC LTD
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077846 HI TECH PHARMA
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078748 SANDOZ INC
DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078981 SANDOZ INC
TRUSOPT DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020408 MERCK

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