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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209085
Company: APOTEX

Products on ANDA 209085

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209085

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2022	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
02/29/2024	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.
02/29/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/29/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209085

PEMETREXED DISODIUM

POWDER;INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203485	ACCORD HLTHCARE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	209085	APOTEX
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	202596	DR REDDYS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214632	EUGIA PHARMA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090384	FRESENIUS KABI USA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215479	MEITHEAL
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214073	ZYDUS PHARMS

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