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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216582
Company: PRINSTON INC

Products on ANDA 216582

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216582

PEMETREXED DISODIUM

POWDER;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALIMTA	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021462	LILLY
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203485	ACCORD HLTHCARE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203774	APOTEX
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214436	BAXTER HLTHCARE CORP
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	202596	DR REDDYS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214632	EUGIA PHARMA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090384	FRESENIUS KABI USA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	208696	JIANGSU HANSOH PHARM
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215479	MEITHEAL
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207352	NANG KUANG PHARM CO
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216582	PRINSTON INC
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204890	QILU PHARM HAINAN
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211899	WAVERLEY PHARMA INC
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214073	ZYDUS PHARMS

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