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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064067
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.

02/05/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

11/27/2001 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/01/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1999 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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.

01/31/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-2 Labeling

Label is not available on this site.

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 064030 AKORN
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
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