Stadol

   
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Stadol


Drug - Stadol
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) - Butorphanol Tartrate
Multiple ingredients are in alphabetical order.

Strength - 1MG/SPRAY
The potency of the active ingredient(s), Butorphanol Tartrate. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Stadol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019890
The FDA assigned number to Stadol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Stadol. 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 - Dec 12, 1991
The date Stadol 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 Stadol. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Stadol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co Pharmaceutical Research Institute
The full name of the firm holding legal responsibility for the new application of Stadol.

Stadol