Drugs@FDA: FDA-Approved Drugs
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
09/26/1983 | 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 |
---|---|---|---|---|---|
05/21/2013 | SUPPL-29 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/23/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
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02/23/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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05/29/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/13/1996 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/27/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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10/27/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/05/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/11/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/11/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/16/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1989 | SUPPL-9 | Manufacturing (CMC) |
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 |