Afrinol

   
Google
 
Web NewDrugInformation.com

Afrinol


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

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

Active Ingredient(s) - Pseudoephedrine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 120MG
The potency of the active ingredient(s), Pseudoephedrine Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018191
The FDA assigned number to Afrinol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Afrinol. 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 Afrinol 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 Afrinol. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Afrinol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Plough Healthcare Products Inc
The full name of the firm holding legal responsibility for the new application of Afrinol.

Afrinol