Prozac

   
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Prozac


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

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

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

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

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

New Drug Application (NDA) Number - 018936
The FDA assigned number to Prozac. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Prozac. 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 - Jun 15, 1999
The date Prozac 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 Prozac. 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 Prozac is in. Format is RX, OTC, DISCN.

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

Prozac