Cyclobenzaprine Hcl

   
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Cyclobenzaprine Hcl


Drug - Cyclobenzaprine Hcl
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 - 10MG
The potency of the active ingredient(s), Cyclobenzaprine Hydrochloride. May repeat for multiple part products.

Applicant - WATSON LABS
The firm name holding legal responsibility for Cyclobenzaprine Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073143
The FDA assigned number to Cyclobenzaprine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cyclobenzaprine Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 27, 1991
The date Cyclobenzaprine Hcl 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 Cyclobenzaprine Hcl. 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 Cyclobenzaprine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Cyclobenzaprine Hcl.

Cyclobenzaprine Hcl