Welchol

   
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Welchol


Drug - Welchol
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) - Colesevelam Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 625MG
The potency of the active ingredient(s), Colesevelam Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021176
The FDA assigned number to Welchol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Welchol. 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 - May 26, 2000
The date Welchol 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 Welchol. 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 Welchol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sankyo Pharma Inc
The full name of the firm holding legal responsibility for the new application of Welchol.

Welchol