Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064030
Company: SENTISS
Company: SENTISS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
07/18/1996 | 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 |
---|---|---|---|---|---|
03/10/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2010 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
ERYTHROMYCIN
OINTMENT;OPHTHALMIC; 0.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064067 | BAUSCH AND LOMB |
ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT;OPHTHALMIC | Prescription | No | AT | 062447 | PADAGIS US |
ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064030 | SENTISS |