Ponstel

   
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Ponstel


Drug - Ponstel
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) - Mefenamic Acid
Multiple ingredients are in alphabetical order.

Strength - 250MG
The potency of the active ingredient(s), Mefenamic Acid. May repeat for multiple part products.

Applicant - FIRST HORIZON
The firm name holding legal responsibility for Ponstel. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 015034
The FDA assigned number to Ponstel. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Ponstel. 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 Ponstel 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 Ponstel. 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 Ponstel is in. Format is RX, OTC, DISCN.

Applicant Full Name - First Horizon Pharmaceutical Corp
The full name of the firm holding legal responsibility for the new application of Ponstel.

Ponstel