Quinidine Sulfate

   
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Quinidine Sulfate


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

Strength - 200MG
The potency of the active ingredient(s), Quinidine Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 083808
The FDA assigned number to Quinidine Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Quinidine Sulfate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Quinidine Sulfate 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 Sulfate. 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 Quinidine Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmaceutical Formulations Inc
The full name of the firm holding legal responsibility for the new application of Quinidine Sulfate.

Quinidine Sulfate