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Approved Drug Products containing 204057 listed in the FDA Orange Book. Original Data : FDA Website

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01 GLENMARK PHARMS (1)

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01 TABLET;ORAL-28 (1)

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01 RX (1)

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01 NORGESTIMATE AND ETHINYL ESTRADIOL (1)

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01 No (1)

URL Supplier Web Content
TABLET; ORAL-28
0.025MG,0.025MG,0....
2016-02-23
204057
NORGESTIMATE AND E...
RX
No
AB
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Looking for FDA Orange Book APPLICATION 204057

Looking for FDA Orange Book APPLICATION 204057 1

19

Glenmark Pharmaceuticals, 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 ETHINYL ESTRADIOL; NORGESTIMATE, with a corresponding application number 204057.

Regulatory Information RX

With a dosage strength 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Dosage Form Route TABLET; ORAL-28

Reference Listed Drug No

Approved since 2016-02-23

Therapeutic Equivalence (TE) Code AB

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