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Approved Drug Products containing 208411 listed in the FDA Orange Book. Original Data : FDA Website

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01 EMERGENT (2)

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01 SPRAY, METERED;NASAL (2)

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01 DISCN (1)

02 OTC (1)

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01 NARCAN (2)

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01 Yes (2)

URL Supplier Web Content
SPRAY, METERED; NA...
4MG/SPRAY
2015-11-18
208411
NARCAN
OTC
Yes
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URL Supplier Web Content
SPRAY, METERED; NA...
2MG/SPRAY **Federa...
2017-01-24
208411
NARCAN
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 208411

Looking for FDA Orange Book APPLICATION 208411 2

19

Emergent BioSolutions, based in U.S.A, is a pharmaceutical company.

One of their notable products is NALOXONE HYDROCHLORIDE, with a corresponding application number 208411.

Regulatory Information OTC

With a dosage strength 4MG/SPRAY

Dosage Form Route SPRAY, METERED; NASAL

Reference Listed Drug Yes

Approved since 2015-11-18

18

Emergent BioSolutions, based in U.S.A, is a pharmaceutical company.

One of their notable products is NALOXONE HYDROCHLORIDE, with a corresponding application number 208411.

Regulatory Information DISCN

With a dosage strength 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY, METERED; NASAL

Reference Listed Drug Yes

Approved since 2017-01-24

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