Application 208927

Type: ANDA
Sponsor: BIOCON LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	100MG	No	No
002	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	500MG	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
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	14974d4e-2f01-4e02-aea2-c28b3ca0781c	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	b185f459-5489-4e18-8521-1686b5d16f67	2022-12-21	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	c9f34c00-1176-4f44-8cff-bae5bdc0c40f	2022-12-08	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED	Teva Pharmaceuticals, Inc.	8b660f68-b770-4e0a-b2f9-25e663deecc3	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed generic name: PEMETREXED
pemetrexed	PEMETREXED DISODIUM	Zydus Pharmaceuticals USA Inc.	363665ca-db15-4123-84ac-0ae66b5f1363	2022-05-26	Warnings, Adverse reactions	Name fallback brand name: pemetrexed
pemetrexed	PEMETREXED DISODIUM	Zydus Lifesciences Limited	6986de29-b077-48ac-ad2b-0cc478f72d89	2022-05-26		Name fallback brand name: pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Qilu Pharmaceutical Co., Ltd.	46a9b89d-7135-4e0c-b8e4-52580554769b	2021-08-13	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed

Reported adverse events (FAERS/openFDA)#

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