Pseudoephedrine Hcl

   
Google
 
Web NewDrugInformation.com

Pseudoephedrine Hcl


Drug - Pseudoephedrine Hcl
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 Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - PERRIGO
The firm name holding legal responsibility for Pseudoephedrine Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075153
The FDA assigned number to Pseudoephedrine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pseudoephedrine Hcl. 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 - Feb 26, 1999
The date Pseudoephedrine Hcl 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 Pseudoephedrine Hcl. 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 Pseudoephedrine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Perrigo Co
The full name of the firm holding legal responsibility for the new application of Pseudoephedrine Hcl.

Pseudoephedrine Hcl