Sudafed 12 Hour

   
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Sudafed 12 Hour


Drug - Sudafed 12 Hour
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 - WARNER LAMBERT
The firm name holding legal responsibility for Sudafed 12 Hour. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073585
The FDA assigned number to Sudafed 12 Hour. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sudafed 12 Hour. 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 - Oct 31, 1991
The date Sudafed 12 Hour 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 Sudafed 12 Hour. 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 Sudafed 12 Hour is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Sudafed 12 Hour.

Sudafed 12 Hour