Propoxyphene Hcl 65


Propoxyphene Hcl 65

Drug - Propoxyphene Hcl 65
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) - Propoxyphene Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 65MG
The potency of the active ingredient(s), Propoxyphene Hydrochloride. May repeat for multiple part products.

The firm name holding legal responsibility for Propoxyphene Hcl 65. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 083786
The FDA assigned number to Propoxyphene Hcl 65. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Propoxyphene Hcl 65. 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 Propoxyphene Hcl 65 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 Propoxyphene Hcl 65. 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 Propoxyphene Hcl 65 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Chilcott Div Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Propoxyphene Hcl 65.

Propoxyphene Hcl 65