Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040716
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (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 |
---|---|---|---|---|---|---|---|
04/30/2007 | 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 |
---|---|---|---|---|---|
08/16/2023 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/07/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
METHOTREXATE SODIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 1GM BASE/40ML (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 PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040716 | ACCORD HLTHCARE |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 011719 | HOSPIRA |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040843 | PHARMACHEMIE BV |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203407 | SAGENT PHARMS INC |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090029 | SANDOZ |