Actos

   
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Actos


Drug - Actos
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) - Pioglitazone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 45MG BASE
The potency of the active ingredient(s), Pioglitazone Hydrochloride. May repeat for multiple part products.

Applicant - TAKEDA PHARMS NA
The firm name holding legal responsibility for Actos. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021073
The FDA assigned number to Actos. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Actos. 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 - Jul 15, 1999
The date Actos 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 Actos. 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 Actos is in. Format is RX, OTC, DISCN.

Applicant Full Name - Takeda Pharmaceuticals North America Inc
The full name of the firm holding legal responsibility for the new application of Actos.

Actos