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Approved Drug Products containing 78633 listed in the FDA Orange Book. Original Data : FDA Website

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01 HIKMA (2)

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01 TABLET;SUBLINGUAL (2)

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01 RX (2)

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01 BUPRENORPHINE HYDROCHLORIDE (2)

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01 No (2)

URL Supplier Web Content
TABLET; SUBLINGUAL
EQ 8MG BASE
2009-10-08
78633
BUPRENORPHINE HYDR...
RX
No
AB
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URL Supplier Web Content
TABLET; SUBLINGUAL
EQ 2MG BASE
2009-10-08
78633
BUPRENORPHINE HYDR...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 78633

Looking for FDA Orange Book APPLICATION 78633 2

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 BUPRENORPHINE HYDROCHLORIDE, with a corresponding application number 78633.

Regulatory Information RX

With a dosage strength EQ 8MG BASE

Dosage Form Route TABLET; SUBLINGUAL

Reference Listed Drug No

Approved since 2009-10-08

Therapeutic Equivalence (TE) Code AB

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 BUPRENORPHINE HYDROCHLORIDE, with a corresponding application number 78633.

Regulatory Information RX

With a dosage strength EQ 2MG BASE

Dosage Form Route TABLET; SUBLINGUAL

Reference Listed Drug No

Approved since 2009-10-08

Therapeutic Equivalence (TE) Code AB

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