Quinine Sulfate

   
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Quinine Sulfate


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

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

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

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

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

New Drug Application (NDA) Number - 021799
The FDA assigned number to Quinine Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Quinine Sulfate. 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 - Aug 12, 2005
The date Quinine 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) - Yes
The pioneer or innovator of Quinine 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 Quinine Sulfate is in. Format is RX, OTC, DISCN.

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

Quinine Sulfate