Quinidine Gluconate

   
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Quinidine Gluconate


Drug - Quinidine Gluconate
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) - Quinidine Gluconate
Multiple ingredients are in alphabetical order.

Strength - 324MG
The potency of the active ingredient(s), Quinidine Gluconate. May repeat for multiple part products.

Applicant - ROXANE
The firm name holding legal responsibility for Quinidine Gluconate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088431
The FDA assigned number to Quinidine Gluconate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Quinidine Gluconate. 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 - Jan 6, 1984
The date Quinidine Gluconate 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 Quinidine Gluconate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Quinidine Gluconate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Quinidine Gluconate.

Quinidine Gluconate