Taxol

   
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Taxol


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Paclitaxel
Multiple ingredients are in alphabetical order.

Strength - 6MG/ML
The potency of the active ingredient(s), Paclitaxel. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020262
The FDA assigned number to Taxol. Format is nnnnnn.

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

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

Approval Date - Dec 29, 1992
The date Taxol 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 Taxol. 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 Taxol 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 Taxol.

Taxol