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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201529

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NDA 201529 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, Sandoz Inc, West-ward Pharms Int, and Pharmachemie Bv, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the METHOTREXATE SODIUM PRESERVATIVE FREE profile page.

The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for 201529

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201529

Suppliers and Packaging for NDA: 201529

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION 201529 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0146 0069-0146-02 5 VIAL in 1 CARTON (0069-0146-02) > 2 mL in 1 VIAL (0069-0146-01)
METHOTREXATE SODIUM PRESERVATIVE FREE
methotrexate sodium
INJECTABLE;INJECTION 201529 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0147 0069-0147-02 10 VIAL in 1 CARTON (0069-0147-02) > 4 mL in 1 VIAL (0069-0147-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:Mar 29, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:Mar 29, 2012TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/8ML (EQ 25MG BASE/ML)
Approval Date:Mar 29, 2012TE:APRLD:No


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