Pamelor

   
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Pamelor


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Nortriptyline Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 75MG BASE
The potency of the active ingredient(s), Nortriptyline Hydrochloride. May repeat for multiple part products.

Applicant - TYCO HLTHCARE
The firm name holding legal responsibility for Pamelor. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018013
The FDA assigned number to Pamelor. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Pamelor. 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 - Approved Prior to Jan 1, 1982
The date Pamelor 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) - Yes
The pioneer or innovator of Pamelor. 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 Pamelor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Tyco Healthcare Group Lp
The full name of the firm holding legal responsibility for the new application of Pamelor.

Pamelor