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Approved Drug Products containing 202788 listed in the FDA Orange Book. Original Data : FDA Website

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01 BTCP PHARMA (7)

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01 SPRAY;SUBLINGUAL (7)

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01 DISCN (7)

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01 SUBSYS (7)

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01 Yes (7)

URL Supplier Web Content
SPRAY; SUBLINGUAL
1.6MG **Federal Re...
2012-08-30
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
0.8MG **Federal Re...
2012-01-04
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
0.4MG **Federal Re...
2012-01-04
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
0.1MG **Federal Re...
2012-01-04
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
1.2MG **Federal Re...
2012-08-30
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
0.6MG **Federal Re...
2012-01-04
202788
SUBSYS
DISCN
Yes
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SPRAY; SUBLINGUAL
0.2MG **Federal Re...
2012-01-04
202788
SUBSYS
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 202788

Looking for FDA Orange Book APPLICATION 202788 7

19

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-08-30

18

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-01-04

17

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-01-04

16

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-01-04

15

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-08-30

14

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-01-04

13

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

One of their notable products is FENTANYL, with a corresponding application number 202788.

Regulatory Information DISCN

With a dosage strength 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SPRAY; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-01-04

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