Ipratropium Bromide

   
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Ipratropium Bromide


Drug - Ipratropium Bromide
The trade name of the product as shown on the labeling.

Dosage - SPRAY, METERED; NASAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ipratropium Bromide
Multiple ingredients are in alphabetical order.

Strength - 0.021MG/SPRAY
The potency of the active ingredient(s), Ipratropium Bromide. May repeat for multiple part products.

Applicant - ROXANE
The firm name holding legal responsibility for Ipratropium Bromide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076664
The FDA assigned number to Ipratropium Bromide. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ipratropium Bromide. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 5, 2003
The date Ipratropium Bromide 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 Ipratropium Bromide. 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 Ipratropium Bromide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Ipratropium Bromide.

Ipratropium Bromide