Reglan Odt

   
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Reglan Odt


Drug - Reglan Odt
The trade name of the product as shown on the labeling.

Dosage - TABLET, ORALLY DISINTEGRATING; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Metoclopramide Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - SCHWARZ PHARMA
The firm name holding legal responsibility for Reglan Odt. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021793
The FDA assigned number to Reglan Odt. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Reglan Odt. 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 - Jun 10, 2005
The date Reglan Odt 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 Reglan Odt. 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 Reglan Odt is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Reglan Odt.

Reglan Odt