Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040168
Company: WOCKHARDT

Products on ANDA 040168

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040168

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.

Labels for ANDA 040168

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