Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208987
Company: SUNSHINE

Products on ANDA 208987

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 208987

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2018	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
08/16/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208987

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