Entocort Ec

   
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Entocort Ec


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

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

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

Strength - 3MG
The potency of the active ingredient(s), Budesonide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021324
The FDA assigned number to Entocort Ec. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Entocort Ec. 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 - Oct 2, 2001
The date Entocort Ec 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 Entocort Ec. 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 Entocort Ec is in. Format is RX, OTC, DISCN.

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

Entocort Ec