Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203243
Company: NOSTRUM LABS INC

Products on ANDA 203243

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/08/2023	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/08/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203243

CLARITHROMYCIN

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	065145	ACTAVIS LABS FL INC
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	065154	DR REDDYS LABS SA
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203243	NOSTRUM LABS INC
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208987	SUNSHINE