Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065123
Company: PADAGIS ISRAEL

Products on ANDA 065123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065123.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/06/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/06/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/06/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/14/2008	SUPPL-5	Labeling		Label is not available on this site.
07/18/2008	SUPPL-4	Labeling		Label is not available on this site.
11/28/2005	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065123

MUPIROCIN

OINTMENT;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	217943	ENCUBE
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	065192	FOUGERA PHARMS
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	090480	GLENMARK PHARMS
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	065123	PADAGIS ISRAEL
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	065170	SUN PHARMA CANADA
MUPIROCIN	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	No	AB	065085	TEVA