Benzonatate
Drug - Benzonatate
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 -
100MG
The potency of the active ingredient(s), Benzonatate. May repeat for multiple part products.
Applicant -
BANNER PHARMACAPS
The firm name holding legal responsibility for Benzonatate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
081297
The FDA assigned number to Benzonatate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Benzonatate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jan 29, 1993
The date Benzonatate 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 Benzonatate. 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 Benzonatate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Banner Pharmacaps Inc
The full name of the firm holding legal responsibility for the new application of Benzonatate.
Benzonatate
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