Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203407
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
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 | No |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (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 |
---|---|---|---|---|---|---|---|
08/09/2018 | ORIG-1 | Approval |
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 |
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 |
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 |