Lithium Carbonate

   
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Lithium Carbonate


Drug - Lithium Carbonate
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) - Lithium Carbonate
Multiple ingredients are in alphabetical order.

Strength - 300MG
The potency of the active ingredient(s), Lithium Carbonate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076832
The FDA assigned number to Lithium Carbonate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lithium Carbonate. 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 - Oct 28, 2004
The date Lithium Carbonate 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 Lithium Carbonate. 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 Lithium Carbonate 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 Lithium Carbonate.

Lithium Carbonate