Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063038
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 2% | SOLUTION;TOPICAL | Prescription | AT | No | 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 |
---|---|---|---|---|---|---|---|
01/11/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/24/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/10/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
ERYTHROMYCIN
SOLUTION;TOPICAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYTHRA-DERM | ERYTHROMYCIN | 2% | SOLUTION;TOPICAL | Prescription | No | AT | 062687 | MICRO LABS |
ERYTHROMYCIN | ERYTHROMYCIN | 2% | SOLUTION;TOPICAL | Prescription | No | AT | 063038 | PADAGIS US |