Motofen

   
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Motofen


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Atropine Sulfate; Difenoxin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.025MG;1MG
The potency of the active ingredient(s), Atropine Sulfate; Difenoxin Hydrochloride. May repeat for multiple part products.

Applicant - VALEANT
The firm name holding legal responsibility for Motofen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017744
The FDA assigned number to Motofen. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Motofen. 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 - Approved Prior to Jan 1, 1982
The date Motofen 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 Motofen. 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 Motofen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Motofen.

Motofen