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Approved Drug Products containing 212516 listed in the FDA Orange Book. Original Data : FDA Website

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01 SUN PHARM (4)

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01 CAPSULE, DELAYED REL PELLETS;ORAL (4)

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01 DISCN (4)

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01 DRIZALMA SPRINKLE (4)

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01 Yes (4)

URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 40MG BASE
2019-07-19
212516
DRIZALMA SPRINKLE
DISCN
Yes
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CAPSULE, DELAYED R...
EQ 20MG BASE
2019-07-19
212516
DRIZALMA SPRINKLE
DISCN
Yes
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CAPSULE, DELAYED R...
EQ 60MG BASE
2019-07-19
212516
DRIZALMA SPRINKLE
DISCN
Yes
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URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 30MG BASE
2019-07-19
212516
DRIZALMA SPRINKLE
DISCN
Yes
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your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 212516

Looking for FDA Orange Book APPLICATION 212516 4

19

Sun Pharmaceutical Industries 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 DULOXETINE HYDROCHLORIDE, with a corresponding application number 212516.

Regulatory Information DISCN

With a dosage strength EQ 40MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug Yes

Approved since 2019-07-19

18

Sun Pharmaceutical Industries 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 DULOXETINE HYDROCHLORIDE, with a corresponding application number 212516.

Regulatory Information DISCN

With a dosage strength EQ 20MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug Yes

Approved since 2019-07-19

17

Sun Pharmaceutical Industries 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 DULOXETINE HYDROCHLORIDE, with a corresponding application number 212516.

Regulatory Information DISCN

With a dosage strength EQ 60MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug Yes

Approved since 2019-07-19

16

Sun Pharmaceutical Industries 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 DULOXETINE HYDROCHLORIDE, with a corresponding application number 212516.

Regulatory Information DISCN

With a dosage strength EQ 30MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug Yes

Approved since 2019-07-19

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