Assyro AI

FDA Orange Book · active-ingredient family

Propoxyphene hydrochloride

Propoxyphene hydrochloride is approved as 1 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DARVON · NDA 010997

1

Brand (NDA)

29

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
DARVON×2XANODYNE PHARMNDA 010997—Approved Prior to Jan 1, 1982

Generic (ANDA) products (29)

ProductApplicantApplicationTEApproved
PROPOXYPHENE HYDROCHLORIDEVINTAGE PHARMSANDA 040908—Jul 17, 2009
PROPOXYPHENE HYDROCHLORIDEMYLANANDA 040569—Dec 16, 2004
PROPOXYPHENE HYDROCHLORIDETEVAANDA 088615—Oct 22, 1984
DOLENEHERITAGE PHARMS INCANDA 080530—Approved Prior to Jan 1, 1982
KESSO-GESICMK LABSANDA 083544—Approved Prior to Jan 1, 1982
PROPHENE 65HALSEYANDA 083538—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEALRAANDA 083184—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEIMPAX LABSANDA 083317—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083597—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEMUTUAL PHARMANDA 083186—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEMYLANANDA 083528—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEMYLANANDA 083299—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDENEXGEN PHARMA INCANDA 083185—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEPAR PHARMANDA 080269—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEPUREPAC PHARMANDA 083278—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEPVT FORMANDA 083464—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEPVT FORMANDA 083113—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDE×2ROXANEANDA 083089—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDESANDOZANDA 084014—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDESANDOZANDA 083125—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDESANDOZANDA 083688—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDESANDOZANDA 083870—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDESANDOZANDA 086495—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEVALEANT PHARM INTLANDA 080783—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEWATSON LABSANDA 080908—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEWATSON LABSANDA 085190—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEWEST WARDANDA 083501—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDEWHITEWORTH TOWN PLSNANDA 084551—Approved Prior to Jan 1, 1982
PROPOXYPHENE HYDROCHLORIDE 65WARNER CHILCOTTANDA 083786—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Propoxyphene hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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