Atrovent Hfa

   
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Atrovent Hfa


Drug - Atrovent Hfa
The trade name of the product as shown on the labeling.

Dosage - AEROSOL, METERED; INHALATION
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/INH
The potency of the active ingredient(s), Ipratropium Bromide. May repeat for multiple part products.

Applicant - BOEHRINGER INGELHEIM
The firm name holding legal responsibility for Atrovent Hfa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021527
The FDA assigned number to Atrovent Hfa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Atrovent Hfa. 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 - Nov 27, 2004
The date Atrovent Hfa 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 Atrovent Hfa. 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 Atrovent Hfa is in. Format is RX, OTC, DISCN.

Applicant Full Name - Boehringer Ingelheim Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Atrovent Hfa.

Atrovent Hfa