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Details for New Drug Application (NDA): 080530

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NDA 080530 describes DOLENE, which is a drug marketed by Heritage Pharms Inc and Lederle and is included in two NDAs. It is available from one supplier. Additional details are available on the DOLENE profile page.

The generic ingredient in DOLENE is acetaminophen; propoxyphene hydrochloride. There are sixty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; propoxyphene hydrochloride profile page.

Summary for NDA: 080530

Heritage Pharms Inc
propoxyphene hydrochloride
Therapeutic Class:Analgesics

Pharmacology for NDA: 080530

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 080530

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
propoxyphene hydrochloride
CAPSULE;ORAL 080530 ANDA Heritage Pharmaceuticals Inc 23155-012 23155-012-01 100 CAPSULE in 1 BOTTLE (23155-012-01)
propoxyphene hydrochloride
CAPSULE;ORAL 080530 ANDA Heritage Pharmaceuticals Inc 23155-012 23155-012-05 500 CAPSULE in 1 BOTTLE (23155-012-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength65MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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