Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019931
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KLARON | SULFACETAMIDE SODIUM | 10% | LOTION;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 |
---|---|---|---|---|---|---|---|
12/23/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019931ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/16/2016 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/05/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/2010 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019931s019ltr.pdf | |
02/21/2003 | SUPPL-8 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19931slr008ltr.pdf | |
10/09/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/09/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/26/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/1999 | 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 |
---|---|---|---|---|---|
07/02/2010 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf | |
02/21/2003 | SUPPL-8 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf |
KLARON
LOTION;TOPICAL; 10%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLARON | SULFACETAMIDE SODIUM | 10% | LOTION;TOPICAL | Prescription | Yes | AB | 019931 | BAUSCH |
SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | LOTION;TOPICAL | Prescription | No | AB | 077015 | FOUGERA PHARMS |
SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | LOTION;TOPICAL | Prescription | No | AB | 078649 | PADAGIS US |
SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | LOTION;TOPICAL | Prescription | No | AB | 078668 | TARO |