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Athena Athena

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Approved Drug Products containing NCGC00024992-03 listed in the FDA Orange Book. Original Data : FDA Website

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01 ACCORD HLTHCARE (3)

02 AIZANT (3)

03 ALEMBIC (2)

04 AMNEAL (3)

05 APOTEX (3)

06 GENENTECH INC (4)

07 GRANULES INDIA (2)

08 HETERO LABS LTD V (2)

09 LAURUS (4)

10 LUPIN LTD (3)

11 MICRO LABS (3)

12 MSN (2)

13 SANDOZ (3)

14 SCIEGEN PHARMS INC (3)

15 TEVA PHARMS USA (2)

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01 CAPSULE;ORAL (8)

02 TABLET;ORAL (34)

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01 DISCN (5)

02 RX (34)

03 Blank (3)

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01 ESBRIET (4)

02 PIRFENIDONE (38)

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01 No (35)

02 Yes (4)

03 Blank (3)

URL Supplier Web Content
CAPSULE;ORAL
267MG
2014-10-15
22535
ESBRIET
RX
Yes
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TABLET;ORAL
267MG
2017-01-11
208780
ESBRIET
RX
Yes
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TABLET;ORAL
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2017-01-11
208780
ESBRIET
DISCN
Yes
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TABLET;ORAL
801MG
2017-01-11
208780
ESBRIET
RX
Yes
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TABLET;ORAL
267MG
2023-08-23
212403
PIRFENIDONE
DISCN
No
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TABLET;ORAL
801MG
2023-08-23
212403
PIRFENIDONE
DISCN
No
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CAPSULE;ORAL
267MG
2023-08-28
212404
PIRFENIDONE
DISCN
No
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CAPSULE;ORAL
267MG
2022-08-01
212077
PIRFENIDONE
RX
No
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TABLET;ORAL
267MG
2022-08-01
212078
PIRFENIDONE
RX
No
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TABLET;ORAL
801MG
2022-08-01
212078
PIRFENIDONE
RX
No
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