Haloperidol Decanoate

   
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Haloperidol Decanoate


Drug - Haloperidol Decanoate
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Haloperidol Decanoate
Multiple ingredients are in alphabetical order.

Strength - EQ 100MG BASE/ML
The potency of the active ingredient(s), Haloperidol Decanoate. May repeat for multiple part products.

Applicant - SABEX 2002
The firm name holding legal responsibility for Haloperidol Decanoate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076463
The FDA assigned number to Haloperidol Decanoate. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Haloperidol 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 - Jun 24, 2005
The date Haloperidol 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 Haloperidol 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 Haloperidol Decanoate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sabex 2002 Inc
The full name of the firm holding legal responsibility for the new application of Haloperidol Decanoate.

Haloperidol Decanoate