Tessalon
Drug - Tessalon
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Benzonatate
Multiple ingredients are in alphabetical order.
Strength -
200MG
The potency of the active ingredient(s), Benzonatate. May repeat for multiple part products.
Applicant -
FOREST LABS
The firm name holding legal responsibility for Tessalon. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
011210
The FDA assigned number to Tessalon. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Tessalon. 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 -
Jun 25, 1999
The date Tessalon 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 Tessalon. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Tessalon is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Forest Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Tessalon.
Tessalon
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