Methotrexate Sodium Preservative Free

   
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Methotrexate Sodium Preservative Free


Drug - Methotrexate Sodium Preservative Free
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 1GM BASE/VIAL
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 Sodium Preservative Free. The firm name is condensed to a maximum twenty character unique string.

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

Product Number - 009
The FDA assigned number to identify Methotrexate Sodium Preservative Free. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Apr 7, 1988
The date Methotrexate Sodium Preservative Free 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 Preservative Free. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Methotrexate Sodium Preservative Free 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 Sodium Preservative Free.

Methotrexate Sodium Preservative Free