Prophene 65
Drug - Prophene 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) -
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.
Applicant -
HALSEY
The firm name holding legal responsibility for Prophene 65. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
083538
The FDA assigned number to Prophene 65. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Prophene 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 Prophene 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 Prophene 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 Prophene 65 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Halsey Drug Co Inc
The full name of the firm holding legal responsibility for the new application of Prophene 65.
Prophene 65
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