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Approved Drug Products containing 212196 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKEM LABS LTD (3)

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01 CAPSULE;ORAL (3)

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01 RX (3)

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01 TIZANIDINE HYDROCHLORIDE (3)

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01 No (3)

URL Supplier Web Content
CAPSULE; ORAL
EQ 6MG BASE
2019-03-27
212196
TIZANIDINE HYDROCH...
RX
No
AB
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URL Supplier Web Content
CAPSULE; ORAL
EQ 2MG BASE
2019-03-27
212196
TIZANIDINE HYDROCH...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
CAPSULE; ORAL
EQ 4MG BASE
2019-03-27
212196
TIZANIDINE HYDROCH...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 212196

Looking for FDA Orange Book APPLICATION 212196 3

19

Alkem Laboratories, 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 TIZANIDINE HYDROCHLORIDE, with a corresponding application number 212196.

Regulatory Information RX

With a dosage strength EQ 6MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2019-03-27

Therapeutic Equivalence (TE) Code AB

18

Alkem Laboratories, 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 TIZANIDINE HYDROCHLORIDE, with a corresponding application number 212196.

Regulatory Information RX

With a dosage strength EQ 2MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2019-03-27

Therapeutic Equivalence (TE) Code AB

17

Alkem Laboratories, 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 TIZANIDINE HYDROCHLORIDE, with a corresponding application number 212196.

Regulatory Information RX

With a dosage strength EQ 4MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2019-03-27

Therapeutic Equivalence (TE) Code AB

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