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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065490
Company: STRIDES PHARMA

Products on ANDA 065490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065490s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/06/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/06/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/03/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065490

VANCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 125MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050606	ANI PHARMS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	No	AB	090439	LUPIN LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	No	AB	210729	ORIENT PHARMA CO LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	No	AB	065490	STRIDES PHARMA

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050606	ANI PHARMS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	090439	LUPIN LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	210729	ORIENT PHARMA CO LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065490	STRIDES PHARMA

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