Darvon W/ Asa
Drug - Darvon W/ Asa
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; Propoxyphene Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
325MG;65MG
The potency of the active ingredient(s), Aspirin; Propoxyphene Hydrochloride. May repeat for multiple part products.
Applicant -
XANODYNE PHARM
The firm name holding legal responsibility for Darvon W/ Asa. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
010996
The FDA assigned number to Darvon W/ Asa. Format is nnnnnn.
Product Number -
005
The FDA assigned number to identify Darvon W/ Asa. 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 Darvon W/ Asa 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 Darvon W/ Asa. 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 Darvon W/ Asa is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Xanodyne Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Darvon W/ Asa.
Darvon W/ Asa
Pravigard Pac (copackaged) 81mg,n/a;n/a,20mg Tablet, Tablet; Oral Pravigard Pac (copackaged) 81mg,n/a;n/a,40mg Tablet, Tablet; Oral Pravigard Pac (copackaged) 81mg,n/a;n/a,80mg Tablet, Tablet; Oral Darvon W/ Asa 325mg;65mg Capsule; Oral Percodan-demi 325mg;2.25mg;0.19mg Tablet; Oral Roxiprin 325mg;4.5mg;0.38mg Tablet; Oral Talwin Compound 325mg;eq 12.5mg Base Tablet; Oral Pravigard Pac (copackaged) 325mg,n/a;n/a,20mg Tablet, Tablet; Oral Pravigard Pac (copackaged) 325mg,n/a;n/a,40mg Tablet, Tablet; Oral Pravigard Pac (copackaged) 325mg,n/a;n/a,80mg Tablet, Tablet; Oral
NewDrugInformation
|
|