Methotrexate

   
Google
 
Web NewDrugInformation.com

Methotrexate


Drug - Methotrexate
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Methotrexate Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 50MG BASE/2ML (25 MG/ML)
The potency of the active ingredient(s), Methotrexate Sodium. May repeat for multiple part products.

Applicant - MAYNE PHARMA USA
The firm name holding legal responsibility for Methotrexate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 011719
The FDA assigned number to Methotrexate. Format is nnnnnn.

Product Number - 010
The FDA assigned number to identify Methotrexate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 15, 2004
The date Methotrexate was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Methotrexate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Methotrexate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mayne Pharma Usa Inc
The full name of the firm holding legal responsibility for the new application of Methotrexate.

Methotrexate