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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203485
Company: ACCORD HLTHCARE

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
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription AP No No
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER;INTRAVENOUS Prescription AP No No

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

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2023 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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

POWDER;INTRAVENOUS; EQ 500MG 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 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021462 LILLY
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 203485 ACCORD HLTHCARE
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 203774 APOTEX
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 214436 BAXTER HLTHCARE CORP
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 202596 DR REDDYS
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 214632 EUGIA PHARMA
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 090384 FRESENIUS KABI USA
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 208696 JIANGSU HANSOH PHARM
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 215479 MEITHEAL
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 207352 NANG KUANG PHARM CO
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 204890 QILU PHARM HAINAN
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 211899 WAVERLEY PHARMA INC
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 214073 ZYDUS PHARMS

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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