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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202190
Company: GLENMARK PHARMS LTD

Products on ANDA 202190

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	No	No
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202190Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/28/2022	SUPPL-5	Labeling-Patient Package Insert		Label is not available on this site.
03/31/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/16/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/16/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202190

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

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