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

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Diphemanil Methylsulfate
Multiple ingredients are in alphabetical order.

Strength - 100MG
The potency of the active ingredient(s), Diphemanil Methylsulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 008114
The FDA assigned number to Prantal. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Prantal. 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 Prantal 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 Prantal. 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 Prantal is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Corp Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Prantal.