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Approved Drug Products containing 6134 listed in the FDA Orange Book. Original Data : FDA Website

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01 HIKMA (3)

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01 SYRUP;ORAL (1)

02 TABLET;ORAL (2)

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01 DISCN (3)

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01 DOLOPHINE HYDROCHLORIDE (3)

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01 No (1)

02 Yes (2)

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SYRUP; ORAL
10MG/30ML
1982-01-01
6134
DOLOPHINE HYDROCHL...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
10MG **Federal Reg...
1982-01-01
6134
DOLOPHINE HYDROCHL...
DISCN
Yes
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TABLET; ORAL
5MG **Federal Regi...
1982-01-01
6134
DOLOPHINE HYDROCHL...
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 6134

Looking for FDA Orange Book APPLICATION 6134 3

19

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHADONE HYDROCHLORIDE, with a corresponding application number 6134.

Regulatory Information DISCN

With a dosage strength 10MG/30ML

Dosage Form Route SYRUP; ORAL

Reference Listed Drug No

Approved since 1982-01-01

18

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHADONE HYDROCHLORIDE, with a corresponding application number 6134.

Regulatory Information DISCN

With a dosage strength 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

17

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHADONE HYDROCHLORIDE, with a corresponding application number 6134.

Regulatory Information DISCN

With a dosage strength 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

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