Decadron-la

   
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Decadron-la


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
The potency of the active ingredient(s), Dexamethasone Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 016675
The FDA assigned number to Decadron-la. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Decadron-la. 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-la 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-la. 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-la is in. Format is RX, OTC, DISCN.

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

Decadron-la