Loratadine And Pseudoephedrine Sulfate

   
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Loratadine And Pseudoephedrine Sulfate


Drug - Loratadine And Pseudoephedrine Sulfate
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) - Loratadine; Pseudoephedrine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 5MG;120MG
The potency of the active ingredient(s), Loratadine; Pseudoephedrine Sulfate. May repeat for multiple part products.

Applicant - IMPAX LABS
The firm name holding legal responsibility for Loratadine And Pseudoephedrine Sulfate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076050
The FDA assigned number to Loratadine And Pseudoephedrine Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Loratadine And Pseudoephedrine Sulfate. 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 - Jan 30, 2003
The date Loratadine And Pseudoephedrine Sulfate 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 Loratadine And Pseudoephedrine Sulfate. 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 Loratadine And Pseudoephedrine Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Impax Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Loratadine And Pseudoephedrine Sulfate.

Loratadine And Pseudoephedrine Sulfate