Application 218751

Type: ANDA
Sponsor: TEVA PHARMACEUTICALS DEVELOPMENT INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	AZACITIDINE	AZACITIDINE	TABLET	300MG	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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZACITIDINE	AZACITIDINE	Eugia US LLC	ecd108bd-bb5f-4b2e-ad91-210fca452e9b	2024-07-23	Warnings, Adverse reactions	Name fallback brand name: AZACITIDINE generic name: AZACITIDINE
Azacitidine	AZACITIDINE	MSN LABORATORIES PRIVATE LIMITED	d24f1fc5-17c6-4e0c-b852-72692e835cff	2024-07-04	Warnings, Adverse reactions	Name fallback brand name: Azacitidine generic name: AZACITIDINE
Azacitidine	AZACITIDINE	Hikma Pharmaceuticals USA Inc.	ff73515d-bd55-4eb5-992b-d2138c80887e	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Azacitidine generic name: AZACITIDINE
VIDAZA	AZACITIDINE	Celgene Corporation	3495a71a-cc04-4776-851f-f185956f32af	2024-01-29	Warnings, Adverse reactions	Name fallback generic name: AZACITIDINE
Azacitidine	AZACITIDINE	BluePoint Laboratories	7f9f1563-f8b2-4e83-a4ec-af41fed0e627	2023-04-21	Warnings, Adverse reactions	Name fallback brand name: Azacitidine generic name: AZACITIDINE
Azacitidine	AZACITIDINE	Panacea Biotec Limited	9abb489d-ce54-4140-83f6-b756f00b0967	2020-10-05	Warnings, Adverse reactions	Name fallback brand name: Azacitidine generic name: AZACITIDINE
AZACITIDINE AZACITIDINE	AZACITIDINE	Dr. Reddy's Laboratories Inc.	d38a1247-28c8-a911-e691-a983a2f9a6e3	2017-07-20	Warnings, Adverse reactions	Name fallback generic name: AZACITIDINE

Reported adverse events (FAERS/openFDA)#

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