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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062447
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.

02/23/2000 SUPPL-21 Labeling

Label is not available on this site.

02/23/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/29/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/27/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/27/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/05/1995 SUPPL-13 Labeling

Label is not available on this site.

07/11/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/16/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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 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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