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Approved Drug Products containing 22569 listed in the FDA Orange Book. Original Data : FDA Website

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01 BTCP PHARMA (3)

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01 SPRAY, METERED;NASAL (3)

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01 DISCN (3)

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01 LAZANDA (3)

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01 Yes (3)

URL Supplier Web Content
SPRAY, METERED; NA...
EQ 0.3MG BASE **Fe...
2015-12-21
22569
LAZANDA
DISCN
Yes
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URL Supplier Web Content
SPRAY, METERED; NA...
EQ 0.1MG BASE **Fe...
2011-06-30
22569
LAZANDA
DISCN
Yes
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SPRAY, METERED; NA...
EQ 0.4MG BASE **Fe...
2011-06-30
22569
LAZANDA
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 22569

Looking for FDA Orange Book APPLICATION 22569 3

19

MMB Healthcare, based in U.S.A, is a pharmaceutical company.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 22569.

Regulatory Information DISCN

With a dosage strength EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2015-12-21

18

MMB Healthcare, based in U.S.A, is a pharmaceutical company.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 22569.

Regulatory Information DISCN

With a dosage strength EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2011-06-30

17

MMB Healthcare, based in U.S.A, is a pharmaceutical company.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 22569.

Regulatory Information DISCN

With a dosage strength EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2011-06-30

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