Sarafem

   
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Sarafem


Drug - Sarafem
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 10MG 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 Sarafem. The firm name is condensed to a maximum twenty character unique string.

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

Product Number - 007
The FDA assigned number to identify Sarafem. 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 - Jul 6, 2000
The date Sarafem 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 Sarafem. 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 Sarafem 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 Sarafem.

Sarafem