Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064184
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 2% | GEL;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
09/30/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/64184ap.pdf |
ERYTHROMYCIN
GEL;TOPICAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYGEL | ERYTHROMYCIN | 2% | GEL;TOPICAL | Prescription | Yes | AT | 050617 | MYLAN |
ERYTHROMYCIN | ERYTHROMYCIN | 2% | GEL;TOPICAL | Prescription | No | AT | 064184 | FOUGERA PHARMS |
ERYTHROMYCIN | ERYTHROMYCIN | 2% | GEL;TOPICAL | Prescription | No | AT | 063211 | PADAGIS US |