Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062746
Company: AZURITY

Products on ANDA 062746

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	250MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062746

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1986	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
03/10/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/10/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-10	Labeling		Label is not available on this site.
07/06/2009	SUPPL-9	Labeling		Label is not available on this site.
04/20/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/17/2004	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062746

ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYC	ERYTHROMYCIN	250MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	Yes	AB	050536	DR REDDYS LABS SA
ERYTHROMYCIN	ERYTHROMYCIN	250MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	062746	AZURITY