Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008085
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET;ORAL Discontinued None Yes 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
12/07/1953 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/04/2020 SUPPL-71 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/008085s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/008085Orig1s071ltr.pdf
03/15/2018 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008085s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008085Orig1s068ltr.pdf
01/29/2016 SUPPL-66 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008085Orig1s066ltr.pdf
12/02/2015 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/16/2019 SUPPL-63 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/31/2006 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/008085s058LTR.pdf
10/24/2003 SUPPL-55 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf
02/20/2002 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
02/20/2002 SUPPL-53 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf
10/24/2003 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf
05/08/2001 SUPPL-51 Labeling

Label is not available on this site.

02/09/2000 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1999 SUPPL-48 Labeling

Label is not available on this site.

06/18/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/08/2000 SUPPL-46 Labeling

Label is not available on this site.

05/20/1997 SUPPL-45 Labeling

Label is not available on this site.

10/05/1990 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1991 SUPPL-39 Labeling

Label is not available on this site.

10/24/1990 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1989 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1989 SUPPL-35 Labeling

Label is not available on this site.

11/16/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/18/1990 SUPPL-32 Labeling

Label is not available on this site.

12/08/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/16/1986 SUPPL-30 Labeling

Label is not available on this site.

10/31/1988 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

10/31/1988 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/19/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1983 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1983 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/05/1979 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/10/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1977 SUPPL-14 Labeling

Label is not available on this site.

04/29/1977 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/26/1976 SUPPL-11

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2020 SUPPL-71 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/008085s071lbl.pdf
03/15/2018 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008085s068lbl.pdf
01/29/2016 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf
01/29/2016 SUPPL-66 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf
10/24/2003 SUPPL-55 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf
10/24/2003 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf

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