U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 011719

Expand all

METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N011719
Product Number: 010
Approval Date: Dec 15, 2004
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N011719
Product Number: 012
Approval Date: Apr 13, 2005
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHOTREXATE LPF (METHOTREXATE SODIUM)
EQ 25MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE LPF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 25MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 007
Approval Date: Mar 31, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 014
Approval Date: Apr 13, 2005
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 013
Approval Date: Apr 13, 2005
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 011
Approval Date: Apr 13, 2005
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 2.5MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 20MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 25MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 25MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 50MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM (METHOTREXATE SODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 1GM BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011719
Product Number: 009
Approval Date: Apr 7, 1988
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top