Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077015
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | LOTION;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/17/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077015s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
SULFACETAMIDE SODIUM
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 |