Delsym

   
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Delsym


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

Dosage - SUSPENSION, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 30MG HBR/5ML
The potency of the active ingredient(s), Dextromethorphan Polistirex. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018658
The FDA assigned number to Delsym. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Delsym. 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 8, 1982
The date Delsym 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 Delsym. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Delsym is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ucb Pharma Inc
The full name of the firm holding legal responsibility for the new application of Delsym.

Delsym