An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	CARNEGIE
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	CARNEGIE
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	CARNEGIE
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	CARNEGIE
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	CARNEGIE
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

Top