Resporal

   
Google
 
Web NewDrugInformation.com

Resporal


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

Strength - 6MG;120MG
The potency of the active ingredient(s), Dexbrompheniramine Maleate; Pseudoephedrine Sulfate. May repeat for multiple part products.

Applicant - PIONEER PHARMS
The firm name holding legal responsibility for Resporal. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089139
The FDA assigned number to Resporal. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Resporal. 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 - Jun 16, 1988
The date Resporal 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 Resporal. 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 Resporal is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pioneer Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Resporal.

Resporal