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Athena Athena

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Approved Drug Products containing 208156 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKEM LABS LTD (1)

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01 SPRAY, METERED;NASAL (1)

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01 RX (1)

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01 AZELASTINE HYDROCHLORIDE (1)

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01 No (1)

URL Supplier Web Content
SPRAY, METERED; NA...
0.137MG/SPRAY
2017-08-18
208156
AZELASTINE HYDROCH...
RX
No
AB
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Looking for FDA Orange Book APPLICATION 208156

Looking for FDA Orange Book APPLICATION 208156 1

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 AZELASTINE HYDROCHLORIDE, with a corresponding application number 208156.

Regulatory Information RX

With a dosage strength 0.137MG/SPRAY

Dosage Form Route SPRAY, METERED; NASAL

Reference Listed Drug No

Approved since 2017-08-18

Therapeutic Equivalence (TE) Code AB

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