Decadron

   
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Decadron


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

Dosage - SOLUTION/DROPS; OPHTHALMIC, OTIC
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.1% PHOSPHATE
The potency of the active ingredient(s), Dexamethasone Sodium Phosphate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 011984
The FDA assigned number to Decadron. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Decadron. 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 - Approved Prior to Jan 1, 1982
The date Decadron 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 Decadron. 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 Decadron is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck And Co Inc
The full name of the firm holding legal responsibility for the new application of Decadron.

Decadron