Metadate Er

   
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Metadate Er


Drug - Metadate Er
The trade name of the product as shown on the labeling.

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

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

Strength - 10MG
The potency of the active ingredient(s), Methylphenidate Hydrochloride. May repeat for multiple part products.

Applicant - UCB
The firm name holding legal responsibility for Metadate Er. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040306
The FDA assigned number to Metadate Er. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Metadate Er. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Oct 20, 1999
The date Metadate Er 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 Metadate Er. 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 Metadate Er is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ucb Pharma Inc
The full name of the firm holding legal responsibility for the new application of Metadate Er.

Metadate Er