Application 202308

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	SOLUTION; OPHTHALMIC	1%	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Proficient Rx LP	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	99ca0089-14a9-446d-8807-253ad5be3efa	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	25f2d819-ae38-4061-a897-bbcfce3739bf	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Inc.	45410338-6bff-476b-b8e1-6c6238205a99	2022-02-25	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Doc Rx	90ff7cfc-73c9-4d77-83df-c05cfbbbbecd	2021-06-11	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sun Pharmaceutical Industries, Inc.	6a22beb6-57e8-480d-97b5-44d9dbfabf93	2020-04-06	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10019	ORIG	2014-02-26