Prochlorperazine Maleate

   
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Prochlorperazine Maleate


Drug - Prochlorperazine Maleate
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) - Prochlorperazine Maleate
Multiple ingredients are in alphabetical order.

Strength - EQ 5MG BASE
The potency of the active ingredient(s), Prochlorperazine Maleate. May repeat for multiple part products.

Applicant - DURAMED PHARMS BARR
The firm name holding legal responsibility for Prochlorperazine Maleate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089484
The FDA assigned number to Prochlorperazine Maleate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prochlorperazine Maleate. 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 - Jan 20, 1987
The date Prochlorperazine Maleate 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 Prochlorperazine Maleate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Prochlorperazine Maleate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Prochlorperazine Maleate.

Prochlorperazine Maleate