Cymbalta

   
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Cymbalta


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

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

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

Strength - EQ 60MG BASE
The potency of the active ingredient(s), Duloxetine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021427
The FDA assigned number to Cymbalta. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Cymbalta. 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 - Aug 3, 2004
The date Cymbalta 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 Cymbalta. 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 Cymbalta is in. Format is RX, OTC, DISCN.

Applicant Full Name - Eli Lilly And Co
The full name of the firm holding legal responsibility for the new application of Cymbalta.

Cymbalta