Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040054
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/01/1994 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
10/29/2020 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
10/29/2020 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
10/29/2020 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040054Orig1s015, s016, s017ltr.pdf
11/26/2007 SUPPL-5 Labeling

Label is not available on this site.

09/13/2006 SUPPL-4 Labeling

Label is not available on this site.

10/30/2001 SUPPL-3 Labeling

Label is not available on this site.

05/07/1998 SUPPL-2 Labeling

Label is not available on this site.

11/10/1994 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf
10/29/2020 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf

METHOTREXATE SODIUM

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 213343 ACCORD HLTHCARE
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 210040 AMNEAL PHARMS
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 081099 BARR
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 210454 EUGIA PHARMA
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 040054 HIKMA
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 209787 LOTUS PHARM CO LTD
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 081235 MYLAN
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 201749 SUN PHARM
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Prescription No AB 207812 ZYDUS PHARMS

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