Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040843
Company: PHARMACHEMIE BV
Company: PHARMACHEMIE BV
| 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 | No |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/08/2010 | 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 |
|---|---|---|---|---|---|
| 08/02/2021 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/24/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2012 | SUPPL-1 | 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 |
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 |
INJECTABLE;INJECTION; EQ 250MG BASE/10ML (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 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040768 | ACCORD HLTHCARE |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 089343 | HIKMA |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040843 | PHARMACHEMIE BV |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203407 | SAGENT PHARMS INC |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090039 | SANDOZ |