Nefazodone Hcl


Nefazodone Hcl

Drug - Nefazodone 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) - Nefazodone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 150MG
The potency of the active ingredient(s), Nefazodone Hydrochloride. May repeat for multiple part products.

The firm name holding legal responsibility for Nefazodone Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076309
The FDA assigned number to Nefazodone Hcl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Nefazodone 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 - Sep 16, 2003
The date Nefazodone 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 Nefazodone 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 Nefazodone Hcl is in. Format is RX, OTC, DISCN.

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

Nefazodone Hcl