Aleve Cold And Sinus


Aleve Cold And Sinus

Drug - Aleve Cold And Sinus
The trade name of the product as shown on the labeling.

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 - BAYER
The firm name holding legal responsibility for Aleve Cold And Sinus. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021076
The FDA assigned number to Aleve Cold And Sinus. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Aleve Cold And Sinus. 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 - Nov 29, 1999
The date Aleve Cold And Sinus 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 Aleve Cold And Sinus. 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 Aleve Cold And Sinus is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Healthcare Llc
The full name of the firm holding legal responsibility for the new application of Aleve Cold And Sinus.

Aleve Cold And Sinus