Actoplus Met

   
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Actoplus Met


Drug - Actoplus Met
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) - Metformin; Pioglitazone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 850MG;EQ 15MG BASE
The potency of the active ingredient(s), Metformin; Pioglitazone Hydrochloride. May repeat for multiple part products.

Applicant - TAKEDA GLOBAL
The firm name holding legal responsibility for Actoplus Met. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021842
The FDA assigned number to Actoplus Met. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Actoplus Met. 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 29, 2005
The date Actoplus Met 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 Actoplus Met. 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 Actoplus Met is in. Format is RX, OTC, DISCN.

Applicant Full Name - Takeda Global Research Development Center Inc
The full name of the firm holding legal responsibility for the new application of Actoplus Met.

Actoplus Met