Nascobal

   
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Nascobal


Drug - Nascobal
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) - Cyanocobalamin
Multiple ingredients are in alphabetical order.

Strength - 0.5MG/SPRAY
The potency of the active ingredient(s), Cyanocobalamin. May repeat for multiple part products.

Applicant - QOL MEDCL
The firm name holding legal responsibility for Nascobal. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021642
The FDA assigned number to Nascobal. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nascobal. 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 - Jan 31, 2005
The date Nascobal 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 Nascobal. 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 Nascobal is in. Format is RX, OTC, DISCN.

Applicant Full Name - Qol Medical Llc
The full name of the firm holding legal responsibility for the new application of Nascobal.

Nascobal