Amitriptyline Hydrochloride

   
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Amitriptyline Hydrochloride


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

Applicant - VINTAGE PHARMS
The firm name holding legal responsibility for Amitriptyline Hydrochloride. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040218
The FDA assigned number to Amitriptyline Hydrochloride. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Amitriptyline Hydrochloride. 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 - Sep 11, 1997
The date Amitriptyline Hydrochloride 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 Amitriptyline Hydrochloride. 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 Amitriptyline Hydrochloride is in. Format is RX, OTC, DISCN.

Applicant Full Name - Vintage Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Amitriptyline Hydrochloride.

Amitriptyline Hydrochloride