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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211776
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION;OPHTHALMIC Prescription AB 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
08/09/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211776Orig1s000ltr.pdf

DIFLUPREDNATE

EMULSION;OPHTHALMIC; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION;OPHTHALMIC Prescription No AB 211526 AMNEAL
DIFLUPREDNATE DIFLUPREDNATE 0.05% EMULSION;OPHTHALMIC Prescription No AB 211776 CIPLA
DUREZOL DIFLUPREDNATE 0.05% EMULSION;OPHTHALMIC Prescription Yes AB 022212 NOVARTIS
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