Methylphenidate Hcl


Methylphenidate Hcl

Drug - Methylphenidate Hcl
The trade name of the product as shown on the labeling.

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 - WATSON LABS
The firm name holding legal responsibility for Methylphenidate Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040220
The FDA assigned number to Methylphenidate Hcl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Methylphenidate Hcl. 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 - Aug 29, 1997
The date Methylphenidate Hcl 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 Methylphenidate Hcl. 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 Methylphenidate Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Methylphenidate Hcl.

Methylphenidate Hcl