Flexeril

   
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Flexeril


Drug - Flexeril
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cyclobenzaprine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 5MG
The potency of the active ingredient(s), Cyclobenzaprine Hydrochloride. May repeat for multiple part products.

Applicant - MCNEIL CONS SPECLT
The firm name holding legal responsibility for Flexeril. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017821
The FDA assigned number to Flexeril. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Flexeril. 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 - Approved Prior to Jan 1, 1982
The date Flexeril 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 Flexeril. 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 Flexeril is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mcneil Consumer And Specialty Pharmaceuticals Div Mcneil Pcc Inc
The full name of the firm holding legal responsibility for the new application of Flexeril.

Flexeril