Symlin

   
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Symlin


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

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

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

Strength - EQ 3MG BASE/5ML (EQ 0.6MG BASE/ML)
The potency of the active ingredient(s), Pramlintide Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021332
The FDA assigned number to Symlin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Symlin. 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 - Mar 16, 2005
The date Symlin 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 Symlin. 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 Symlin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Amylin Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Symlin.

Symlin