Trovan/zithromax Compliance Pak

   
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Trovan/zithromax Compliance Pak


Drug - Trovan/zithromax Compliance Pak
The trade name of the product as shown on the labeling.

Dosage - FOR SUSPENSION; TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Azithromycin Dihydrate; Trovafloxacin Mesylate
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
The potency of the active ingredient(s), Azithromycin Dihydrate; Trovafloxacin Mesylate. May repeat for multiple part products.

Applicant - PFIZER
The firm name holding legal responsibility for Trovan/zithromax Compliance Pak. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050762
The FDA assigned number to Trovan/zithromax Compliance Pak. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Trovan/zithromax Compliance Pak. 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 18, 1998
The date Trovan/zithromax Compliance Pak 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 Trovan/zithromax Compliance Pak. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Trovan/zithromax Compliance Pak is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Trovan/zithromax Compliance Pak.

Trovan/zithromax Compliance Pak