Navelbine

   
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Navelbine


Drug - Navelbine
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) - Vinorelbine Tartrate
Multiple ingredients are in alphabetical order.

Strength - EQ 10MG BASE/ML
The potency of the active ingredient(s), Vinorelbine Tartrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020388
The FDA assigned number to Navelbine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Navelbine. 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 23, 1994
The date Navelbine 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 Navelbine. 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 Navelbine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Navelbine.

Navelbine