Fluphenazine Decanoate
Drug - Fluphenazine Decanoate
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; IM-SC
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Fluphenazine Decanoate
Multiple ingredients are in alphabetical order.
Strength -
25MG/ML
The potency of the active ingredient(s), Fluphenazine Decanoate. May repeat for multiple part products.
Applicant -
APOTEX
The firm name holding legal responsibility for Fluphenazine Decanoate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075918
The FDA assigned number to Fluphenazine Decanoate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Fluphenazine Decanoate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AO
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Aug 17, 2001
The date Fluphenazine Decanoate 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 Fluphenazine Decanoate. 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 Fluphenazine Decanoate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Apotex Corp
The full name of the firm holding legal responsibility for the new application of Fluphenazine Decanoate.
Fluphenazine Decanoate
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