Fortical

   
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Fortical


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

Dosage - SPRAY, METERED; NASAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Calcitonin Salmon Recombinant
Multiple ingredients are in alphabetical order.

Strength - 200 IU/SPRAY
The potency of the active ingredient(s), Calcitonin Salmon Recombinant. May repeat for multiple part products.

Applicant - UNIGENE
The firm name holding legal responsibility for Fortical. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021406
The FDA assigned number to Fortical. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fortical. 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 - Aug 12, 2005
The date Fortical 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 Fortical. 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 Fortical is in. Format is RX, OTC, DISCN.

Applicant Full Name - Unigene Laboratories
The full name of the firm holding legal responsibility for the new application of Fortical.

Fortical