Cipro Xr

   
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Cipro Xr


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ciprofloxacin; Ciprofloxacin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 212.6MG;EQ 287.5MG BASE
The potency of the active ingredient(s), Ciprofloxacin; Ciprofloxacin Hydrochloride. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Cipro Xr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021473
The FDA assigned number to Cipro Xr. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cipro Xr. 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 13, 2002
The date Cipro Xr 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 Cipro Xr. 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 Cipro Xr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Cipro Xr.

Cipro Xr