Methotrexate Sodium

   
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Methotrexate Sodium


Drug - Methotrexate Sodium
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 200MG BASE/8ML (25 MG/ML)
The potency of the active ingredient(s), Methotrexate Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 089342
The FDA assigned number to Methotrexate Sodium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Methotrexate Sodium. 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 - Sep 16, 1986
The date Methotrexate Sodium 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) - No
The pioneer or innovator of Methotrexate Sodium. 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 Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bedford Laboratories Div Ben Venue Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Methotrexate Sodium.

Methotrexate Sodium