Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210316
Company: ALKEM LABS LTD

Products on ANDA 210316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210316

COLESEVELAM HYDROCHLORIDE

FOR SUSPENSION;ORAL; 3.75GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	210316	ALKEM LABS LTD
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	202190	GLENMARK PHARMS LTD
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	212886	IMPAX
WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	022362	COSETTE