Pulmicort

   
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Pulmicort


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

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

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

Strength - 0.32MG/INH
The potency of the active ingredient(s), Budesonide. May repeat for multiple part products.

Applicant - ASTRAZENECA
The firm name holding legal responsibility for Pulmicort. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020441
The FDA assigned number to Pulmicort. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Pulmicort. 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 - Jun 24, 1997
The date Pulmicort 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 Pulmicort. 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 Pulmicort is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Pharmaceuticals Lp
The full name of the firm holding legal responsibility for the new application of Pulmicort.

Pulmicort