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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061904
Company: AZURITY

Products on ANDA 061904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET;ORAL	Prescription	BX	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/1975	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
01/17/2020	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
01/17/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
07/24/2013	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/04/2013	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061904Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/061904Orig1s021ltr.pdf
09/18/2009	SUPPL-18	Labeling		Label is not available on this site.
03/15/2007	SUPPL-14	Labeling		Label is not available on this site.
01/03/2003	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/2001	SUPPL-11	Labeling		Label is not available on this site.
04/20/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/29/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/18/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 061904

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2013	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061904Orig1s021lbl.pdf

Therapeutic Equivalents for ANDA 061904

ERYTHROMYCIN ETHYLSUCCINATE

There are no Therapeutic Equivalents.

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