Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
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 |
---|---|---|---|---|---|---|---|
07/29/1994 | 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 |
---|---|---|---|---|---|
08/20/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/05/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/27/2001 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/07/2001 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2000 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/01/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/07/1999 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/31/1999 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/31/1999 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/04/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/21/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/31/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/24/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/01/1995 | SUPPL-1 | 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 |