Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020769
Company: PRECISION DERMAT
Company: PRECISION DERMAT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOCOID LIPOCREAM | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | AB2 | Yes | 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 |
---|---|---|---|---|---|---|---|
09/08/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020769_locoid_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020769Orig1s014ltr.pdf | |
09/04/2009 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/19/2009 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020769s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020769s011ltr.pdf | |
04/21/2006 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020769s009LTR.pdf |
08/23/2004 | SUPPL-3 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20769s003ltr.pdf |
03/12/1998 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/20/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf | |
10/19/2009 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020769s011lbl.pdf |
LOCOID LIPOCREAM
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 |