Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075043
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/25/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/04/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/29/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
04/27/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/21/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/25/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf |
HYDROCORTISONE VALERATE
OINTMENT;TOPICAL; 0.2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 211764 | COSETTE |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 211750 | GLENMARK PHARMS LTD |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | OINTMENT;TOPICAL | Prescription | No | AB | 075043 | TARO |