Baciim

   
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Baciim


Drug - Baciim
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) - Bacitracin
Multiple ingredients are in alphabetical order.

Strength - 50,000 UNITS/VIAL
The potency of the active ingredient(s), Bacitracin. May repeat for multiple part products.

Applicant - PHARMA TEK
The firm name holding legal responsibility for Baciim. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 064153
The FDA assigned number to Baciim. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Baciim. 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 - May 9, 1997
The date Baciim 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 Baciim. 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 Baciim is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharma Tek Inc
The full name of the firm holding legal responsibility for the new application of Baciim.

Baciim