Renagel

   
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Renagel


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

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

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

Strength - 800MG
The potency of the active ingredient(s), Sevelamer Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021179
The FDA assigned number to Renagel. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Renagel. 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 12, 2000
The date Renagel 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 Renagel. 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 Renagel is in. Format is RX, OTC, DISCN.

Applicant Full Name - Genzyme Corp
The full name of the firm holding legal responsibility for the new application of Renagel.

Renagel