Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062447
Company: PADAGIS US

Products on ANDA 062447

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062447

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.