Bleomycin Sulfate


Bleomycin Sulfate

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

The product dosage form and route separated by a semi-colon.

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

Strength - EQ 15 UNITS BASE/VIAL
The potency of the active ingredient(s), Bleomycin Sulfate. May repeat for multiple part products.

Applicant - SICOR PHARMS
The firm name holding legal responsibility for Bleomycin Sulfate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 064084
The FDA assigned number to Bleomycin Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bleomycin Sulfate. 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 - Jun 1, 1996
The date Bleomycin Sulfate 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 Bleomycin Sulfate. 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 Bleomycin Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sicor Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Bleomycin Sulfate.

Bleomycin Sulfate