Tilade

   
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Tilade


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

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

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

Strength - 0.5%
The potency of the active ingredient(s), Nedocromil Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020750
The FDA assigned number to Tilade. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tilade. 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 1, 1997
The date Tilade 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 Tilade. 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 Tilade is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Tilade.

Tilade