Diamox

   
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Diamox


Drug - Diamox
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) - Acetazolamide Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG BASE/VIAL
The potency of the active ingredient(s), Acetazolamide Sodium. May repeat for multiple part products.

Applicant - DURAMED PHARMS BARR
The firm name holding legal responsibility for Diamox. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 009388
The FDA assigned number to Diamox. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Diamox. 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 5, 1990
The date Diamox 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 Diamox. 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 Diamox is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Diamox.

Diamox