Drug - Methylin Er
The trade name of the product as shown on the labeling.
TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Multiple ingredients are in alphabetical order.
The potency of the active ingredient(s), Methylphenidate Hydrochloride. May repeat for multiple part products.
The firm name holding legal responsibility for Methylin Er. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
The FDA assigned number to Methylin Er. Format is nnnnnn.
Product Number -
The FDA assigned number to identify Methylin Er. 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 -
May 9, 2000
The date Methylin 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) -
The pioneer or innovator of Methylin Er. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
The group or category of approved drugs Methylin Er is in. Format is RX, OTC, DISCN.
Applicant Full Name -
The full name of the firm holding legal responsibility for the new application of Methylin Er.
Methylin Er 20mg Tablet, Extended Release; Oral Methylin 2.5mg Tablet, Chewable; Oral Methylin 5mg Tablet, Chewable; Oral Concerta 18mg Tablet, Extended Release; Oral Concerta 27mg Tablet, Extended Release; Oral Concerta 36mg Tablet, Extended Release; Oral Concerta 54mg Tablet, Extended Release; Oral Metadate Er 10mg Tablet, Extended Release; Oral Metadate Er 20mg Tablet, Extended Release; Oral Methylin Er 10mg Tablet, Extended Release; Oral