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): 210000
Company: BIONPHARMA

Products on ANDA 210000

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2023	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/05/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210000

AZITHROMYCIN

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	211791	ALEMBIC
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	207370	AUROBINDO PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	210000	BIONPHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065404	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	208250	CSPC OUYI
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065398	LUPIN LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065225	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065211	SANDOZ
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	209045	SUNSHINE
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	211317	YUNG SHIN PHARM
ZITHROMAX	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	Yes	AB	050711	PFIZER

Top