Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018652
Company: PRECISION DERMAT
Company: PRECISION DERMAT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | OINTMENT;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/29/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018652Orig1s010ltr.pdf | |
05/03/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/16/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/25/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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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-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf |
LOCOID
OINTMENT;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE | 0.1% | OINTMENT;TOPICAL | Prescription | No | AB | 076842 | TARO |
LOCOID | HYDROCORTISONE BUTYRATE | 0.1% | OINTMENT;TOPICAL | Prescription | Yes | AB | 018652 | PRECISION DERMAT |