Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203485
Company: ACCORD HLTHCARE
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 | 215460 | HETERO LABS LTD VI |
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 | RELIANCE LIFE |
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 | 215460 | HETERO LABS LTD VI |
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 | RELIANCE LIFE |
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 |