Disophrol

   
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Disophrol


Drug - Disophrol
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) - Dexbrompheniramine Maleate; Pseudoephedrine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 2MG;60MG
The potency of the active ingredient(s), Dexbrompheniramine Maleate; Pseudoephedrine Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 012394
The FDA assigned number to Disophrol. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Disophrol. 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 Disophrol 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 Disophrol. 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 Disophrol 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 Disophrol.

Disophrol