Ritalin-sr
Drug - Ritalin-sr
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 -
20MG
The potency of the active ingredient(s), Methylphenidate Hydrochloride. May repeat for multiple part products.
Applicant -
NOVARTIS
The firm name holding legal responsibility for Ritalin-sr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018029
The FDA assigned number to Ritalin-sr. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Ritalin-sr. 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 -
Mar 30, 1982
The date Ritalin-sr 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 Ritalin-sr. 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 Ritalin-sr is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Ritalin-sr.
Ritalin-sr
Methylin Er 20mg Tablet, Extended Release; Oral Methylphenidate Hcl 20mg Tablet, Extended Release; Oral Methylphenidate Hcl 20mg Tablet, Extended Release; Oral Methylphenidate Hcl 20mg Tablet, Extended Release; Oral Ritalin-sr 20mg 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
NewDrugInformation
|