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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062055
Company: ANI PHARMS

Products on ANDA 062055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	AB	No	No
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	AB	No	No
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1978	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
11/02/2018	SUPPL-35	Manufacturing (CMC)-New Strength	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/062055Orig1s035.pdf
11/02/2018	SUPPL-34	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/062055Orig1s034.pdf
04/25/2014	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
06/01/2001	SUPPL-31	Labeling		Label is not available on this site.
05/24/2001	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
02/14/2001	SUPPL-29	Labeling		Label is not available on this site.
12/21/1999	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
05/20/1999	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
10/08/1998	SUPPL-26	Labeling		Label is not available on this site.
12/01/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/22/1995	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/01/1993	SUPPL-20	Labeling		Label is not available on this site.
04/03/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/25/1992	SUPPL-16	Labeling		Label is not available on this site.
04/29/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062055

ERYTHROMYCIN ETHYLSUCCINATE

GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

GRANULE;ORAL; EQ 400MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

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