Endep
Drug - Endep
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Amitriptyline Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
150MG
The potency of the active ingredient(s), Amitriptyline Hydrochloride. May repeat for multiple part products.
Applicant -
ROCHE
The firm name holding legal responsibility for Endep. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
085303
The FDA assigned number to Endep. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Endep. 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 -
Approved Prior to Jan 1, 1982
The date Endep 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 Endep. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Endep is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Endep.
Endep
|
