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Approved Drug Products containing 78643 listed in the FDA Orange Book. Original Data : FDA Website

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01 AUROBINDO PHARMA (2)

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01 TABLET;ORAL (2)

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01 RX (2)

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01 CYCLOBENZAPRINE HYDROCHLORIDE (2)

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01 No (2)

URL Supplier Web Content
TABLET; ORAL
5MG
2008-09-26
78643
CYCLOBENZAPRINE HY...
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
10MG
2008-09-26
78643
CYCLOBENZAPRINE HY...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 78643

Looking for FDA Orange Book APPLICATION 78643 2

19

Aurobindo Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is CYCLOBENZAPRINE HYDROCHLORIDE, with a corresponding application number 78643.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2008-09-26

Therapeutic Equivalence (TE) Code AB

18

Aurobindo Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is CYCLOBENZAPRINE HYDROCHLORIDE, with a corresponding application number 78643.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2008-09-26

Therapeutic Equivalence (TE) Code AB

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