Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075042
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;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/anda/98/75-042_prntlbl.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075042_hydrocortisone_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/08/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/15/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/16/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1999 | 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/anda/98/75-042_prntlbl.PDF |
HYDROCORTISONE VALERATE
CREAM;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% | CREAM;TOPICAL | Prescription | No | AB | 213724 | COSETTE |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;TOPICAL | Prescription | No | AB | 211047 | ENCUBE ETHICALS |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;TOPICAL | Prescription | No | AB | 211129 | GLENMARK PHARMS LTD |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;TOPICAL | Prescription | No | AB | 210307 | LUPIN LTD |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;TOPICAL | Prescription | No | AB | 075666 | PADAGIS ISRAEL |
HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | 0.2% | CREAM;TOPICAL | Prescription | No | AB | 075042 | TARO |