Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202145
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
09/27/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202145Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/08/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/27/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf |
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL; 0.1%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | No | AB2 | 205134 | ACTAVIS MID ATLANTIC |
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | No | AB2 | 202145 | GLENMARK PHARMS LTD |
LOCOID LIPOCREAM | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB2 | 020769 | PRECISION DERMAT |