Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040168
Company: WOCKHARDT
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 |