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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201587
Company: GLENMARK PHARMS

Products on ANDA 201587

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201587

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2013	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201587Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201587Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2024	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/08/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/16/2019	SUPPL-9	Labeling-Proprietary Name Change		Label is not available on this site.
10/30/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/30/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/30/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/30/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201587

MUPIROCIN

CREAM;TOPICAL; EQ 2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	214811	AMNEAL
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	213076	ENCUBE
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	201587	GLENMARK PHARMS
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	207116	SUN PHARMA CANADA

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