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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089342
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription AP 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
09/16/1986 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
10/25/2021 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
10/25/2021 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
10/25/2021 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
02/05/2013 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
04/25/2011 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
04/03/2001 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
09/19/2000 SUPPL-20 Labeling

Label is not available on this site.
05/24/2000 SUPPL-17 Labeling

Label is not available on this site.
11/17/1999 SUPPL-16 Labeling

Label is not available on this site.
09/22/1999 SUPPL-15 Labeling

Label is not available on this site.
01/28/1999 SUPPL-14 Labeling

Label is not available on this site.
06/11/1998 SUPPL-13 Labeling

Label is not available on this site.
08/11/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
05/12/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
11/05/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
05/03/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
01/15/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/18/1990 SUPPL-7 Labeling

Label is not available on this site.
04/25/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
07/20/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METHOTREXATE SODIUM

INJECTABLE;INJECTION; EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 089342 HIKMA
METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201529 EUGIA PHARMA SPECLTS
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