Amitriptyline Hcl

   
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Amitriptyline Hcl


Drug - Amitriptyline Hcl
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 - 25MG
The potency of the active ingredient(s), Amitriptyline Hydrochloride. May repeat for multiple part products.

Applicant - WEST WARD
The firm name holding legal responsibility for Amitriptyline Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087278
The FDA assigned number to Amitriptyline Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Amitriptyline Hcl. 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 Amitriptyline 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 Amitriptyline Hcl. 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 Amitriptyline Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - West Ward Pharmaceutical Corp
The full name of the firm holding legal responsibility for the new application of Amitriptyline Hcl.

Amitriptyline Hcl