Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018514
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
03/31/1982 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/30/2014 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018514Orig1s013ltr.pdf | |
01/08/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/12/2005 | SUPPL-9 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018514s009ltr.pdf |
05/22/2002 | SUPPL-8 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18514s008ltr.pdf |
08/30/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/1996 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/25/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/20/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/30/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf |
LOCOID
CREAM;TOPICAL; 0.1%
TE Code = AB1
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 | AB1 | 076654 | TARO PHARM INDS |
LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB1 | 018514 | BAUSCH |