Miacalcin

   
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Miacalcin


Drug - Miacalcin
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
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020313
The FDA assigned number to Miacalcin. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Miacalcin. 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 17, 1995
The date Miacalcin 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 Miacalcin. 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 Miacalcin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Miacalcin.

Miacalcin