Naproxen Sodium And Pseudoephedrine Hcl

   
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Naproxen Sodium And Pseudoephedrine Hcl


Drug - Naproxen Sodium And 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) - Naproxen Sodium; Pseudoephedrine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 200MG BASE;120MG
The potency of the active ingredient(s), Naproxen Sodium; Pseudoephedrine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076518
The FDA assigned number to Naproxen Sodium And Pseudoephedrine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Naproxen Sodium And 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 - Mar 17, 2004
The date Naproxen Sodium And 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 Naproxen Sodium And 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 Naproxen Sodium And Pseudoephedrine Hcl is in. Format is RX, OTC, DISCN.

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

Naproxen Sodium And Pseudoephedrine Hcl