← FDA DRUG APPROVALS

FDA NDA · NDA020533

NAROPIN

ropivacaine hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION

NDA020533

TYPE

NDA

ORIGINAL APPROVAL

1996-09-24

LATEST ACTION

2022-06-28

ROUTE

EPIDURAL, INFILTRATION, PERINEURAL, INJECTION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription, Discontinued

Products

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferenceDiscontinued

ROPIVACAINE HYDROCHLORIDE 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferenceDiscontinued

ROPIVACAINE HYDROCHLORIDE 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) · SOLUTION · INJECTION

NAROPIN · ReferencePrescription

ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) · SOLUTION · INJECTION

Approval history

2022-06-28Labeling · Supplement 44 · standard — Letter ↗AP

2022-06-15Labeling · Supplement 38 · standard — Letter ↗AP

2018-11-02Labeling · Supplement 35 · standard — Label ↗AP

2018-02-15UNKNOWN · Supplement 34 · standard — Letter ↗AP

2016-06-06Manufacturing (CMC) · Supplement 32 · standardAP

2014-10-29Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP

2013-04-21Manufacturing (CMC) · Supplement 24 · standardAP

2013-02-16Manufacturing (CMC) · Supplement 30 · standardAP

2012-12-26Manufacturing (CMC) · Supplement 28 · standard — Label ↗AP

2012-11-15Manufacturing (CMC) · Supplement 27 · standardAP

2012-11-09Manufacturing (CMC) · Supplement 29 · standard — Label ↗AP

2010-02-19Labeling · Supplement 20 · 901 required — Letter ↗AP

2010-02-19Labeling · Supplement 21 · standard — Label ↗AP

2006-08-08Labeling · Supplement 14 · standard — Letter ↗AP

2004-08-11Labeling · Supplement 12 · standard — Label ↗AP

2002-07-17Manufacturing (CMC) · Supplement 8 · standardAP

2000-11-14Manufacturing (CMC) · Supplement 7 · standardAP

2000-11-02Efficacy · Supplement 2 · standard — Review ↗AP

2000-06-22Labeling · Supplement 5 · standardAP

2000-02-09Manufacturing (CMC) · Supplement 6 · standardAP

1998-05-01Manufacturing (CMC) · Supplement 1 · standardAP

1996-09-24Type 1 - New Molecular Entity · Original · standard — Review ↗AP

VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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