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FDA NDA · NDA022442

REZIRA

Sponsor: PERSION

APPLICATION
NDA022442
TYPE
NDA
ORIGINAL APPROVAL
2011-06-08
LATEST ACTION
2018-06-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

REZIRA · ReferenceDiscontinued
HYDROCODONE BITARTRATE 5MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2018-06-28Labeling · Supplement 10 · standard — Label ↗AP
2017-01-13Labeling · Supplement 9 · standard — Label ↗AP
2011-06-08Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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