Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (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-41 | Labeling-Package Insert |
Label is not available on this site. |
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10/25/2021 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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10/25/2021 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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02/05/2013 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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04/25/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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04/03/2001 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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09/19/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/24/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/17/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
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09/22/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
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01/28/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/11/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
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08/11/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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11/05/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/15/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/25/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/25/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/20/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METHOTREXATE SODIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 50MG BASE/2ML (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 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040263 | FRESENIUS KABI USA |
METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 011719 | HOSPIRA |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040767 | ACCORD HLTHCARE |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 089340 | HIKMA |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040843 | PHARMACHEMIE BV |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203407 | SAGENT PHARMS INC |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090039 | SANDOZ |