Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207609
Company: HI TECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS;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
04/17/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207609Orig1s000ltr.pdf

LOTEPREDNOL ETABONATE

SUSPENSION/DROPS;OPHTHALMIC; 0.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOTEMAX LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 020583 BAUSCH AND LOMB
LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 207609 HI TECH

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