Is HP Halden Pharma AS FDA approved?

HP Halden Pharma AS holds 1 FDA-registered establishment in Norway. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are HP Halden Pharma AS's drugs manufactured?

The FDA register lists Halden. Registered operations: analytical testing, finished drug manufacture, packaging.

What drugs does HP Halden Pharma AS make?

9 products are listed under HP Halden Pharma AS in the openFDA NDC Directory, most often as injection, solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

HP Halden Pharma AS

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 9
Labeller names: 2
Live patents: 0
Countries: 1
Base: Norway

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
HP Halden Pharma AS	Svinesundsveien 80, Halden, OSTFOLD NO-1788, Norway (NOR)	Analytical testing, Finished drug manufacture, Packaging	3002608066347747373

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human prescription drug. By marketing category: ANDA 5, NDA 4.

Dosage form	NDCs
injection, solution	5
injection	4

Route	NDCs
intravenous	9

Labeller name on the listing	NDCs
hp halden pharma as	8
hp halden pharma as	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Levetiracetam	LEVETIRACETAM	injection, intravenous	66298-0427ANDA
Levetiracetam	LEVETIRACETAM	injection, intravenous	66298-0447ANDA
Levetiracetam	LEVETIRACETAM	injection, intravenous	66298-0467ANDA
Linezolid	LINEZOLID	injection, solution, intravenous	66298-7131ANDA
Moxifloxacin	MOXIFLOXACIN HYDROCHLORIDE	injection, solution, intravenous	66298-8507NDA
Tranexamic Acid in Sodium Chloride	TRANEXAMIC ACID	injection, solution, intravenous	66298-5340ANDA
Zyvox	LINEZOLID	injection, solution, intravenous	66298-5137NDA
Zyvox	linezolid	injection, solution, intravenous	66298-5140NDA
Zyvox	LINEZOLID	injection, intravenous	66298-7807NDA

Compare

Comparable companies in Norway

Vistin Pharma AS1 site · 3 NDC
GE Healthcare Inc.5 sites · 14 NDC

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Common questions

Is HP Halden Pharma AS FDA approved?: HP Halden Pharma AS holds 1 FDA-registered establishment in Norway. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are HP Halden Pharma AS's drugs manufactured?: The FDA register lists Halden. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does HP Halden Pharma AS make?: 9 products are listed under HP Halden Pharma AS in the openFDA NDC Directory, most often as injection, solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.