Propoxyphene Compound 65

   
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Propoxyphene Compound 65


Drug - Propoxyphene Compound 65
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) - Aspirin; Caffeine; Propoxyphene Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 389MG;32.4MG;65MG
The potency of the active ingredient(s), Aspirin; Caffeine; Propoxyphene Hydrochloride. May repeat for multiple part products.

Applicant - SANDOZ
The firm name holding legal responsibility for Propoxyphene Compound 65. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 080044
The FDA assigned number to Propoxyphene Compound 65. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Propoxyphene Compound 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 - Sep 16, 1983
The date Propoxyphene Compound 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 Compound 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 Compound 65 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sandoz Inc
The full name of the firm holding legal responsibility for the new application of Propoxyphene Compound 65.

Propoxyphene Compound 65