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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061621
Company: AZURITY

Products on ANDA 061621

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	AB	No	No
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061621

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/1972	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/061621Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2019	SUPPL-43	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/061621Orig1s043LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/061621Orig1s043ltr.pdf
07/24/2013	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
12/04/2013	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061621s039lbl.pdf
09/24/2009	SUPPL-38	Labeling		Label is not available on this site.
07/02/2009	SUPPL-37	Labeling		Label is not available on this site.
07/03/2006	SUPPL-35	Labeling		Label is not available on this site.
03/17/2004	SUPPL-33	Labeling		Label is not available on this site.
07/18/2000	SUPPL-29	Manufacturing (CMC)-Facility		Label is not available on this site.
07/26/2000	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
07/26/2000	SUPPL-27	Labeling		Label is not available on this site.
07/26/2000	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
07/26/2000	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/26/2000	SUPPL-24	Labeling		Label is not available on this site.
04/20/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 061621

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2019	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/061621Orig1s043LBL.pdf
12/04/2013	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061621s039lbl.pdf

Therapeutic Equivalents for ANDA 061621

ERYTHROMYCIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	209720	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	061621	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	209720	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	061621	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

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