Choledyl Sa

   
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Choledyl Sa


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

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

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

Strength - 600MG
The potency of the active ingredient(s), Oxtriphylline. May repeat for multiple part products.

Applicant - WARNER CHILCOTT
The firm name holding legal responsibility for Choledyl Sa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086742
The FDA assigned number to Choledyl Sa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Choledyl Sa. 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 - Approved Prior to Jan 1, 1982
The date Choledyl Sa 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 Choledyl Sa. 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 Choledyl Sa is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Chilcott Bermuda Ltd
The full name of the firm holding legal responsibility for the new application of Choledyl Sa.

Choledyl Sa