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Details for New Drug Application (NDA): 204278

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NDA 204278 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Hospira Inc, Nesher Pharms, Aurolife Pharma Llc, Watson Labs, Elite Labs, Akorn, Osmotica, Lannett, Barr, Actavis Labs Fl Inc, Roxane, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen NDAs. It is available from nineteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are thirteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 204278

Tradename:
HYDROMORPHONE HYDROCHLORIDE
Applicant:
Paddock Llc
Ingredient:
hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 204278

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 204278

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0293 0574-0293-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0293-01)
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0294 0574-0294-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Apr 6, 2015TE:ABRLD:No


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