Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040168
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Discontinued None 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
08/30/1996 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone%20and%20Acetic%20Acid%20Otic_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone%20and%20Acetic%20Acid%20Otic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040168_hydrocortisone-aceticacid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/1996 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40168_Hydrocortisone%20and%20Acetic%20Acid%20Otic_Prntlbl.pdf

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