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Athena Athena

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

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01 LUPIN LTD (1)

02 VERTEX PHARMS (1)

03 VERTEX PHARMS INC (16)

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01 GRANULE;ORAL (8)

02 GRANULES;ORAL (2)

03 TABLET; ORAL (1)

04 TABLET;ORAL (7)

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01 RX (17)

02 Blank (1)

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01 IVACAFTOR (1)

02 KALYDECO (6)

03 ORKAMBI (5)

04 SYMDEKO (COPACKAGED) (2)

05 TRIKAFTA (COPACKAGED) (4)

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01 Yes (17)

02 Blank (1)

URL Supplier Web Content
TABLET;ORAL
150MG
2012-01-31
203188
KALYDECO
RX
Yes
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TABLET;ORAL
125MG;200MG
2015-07-02
206038
ORKAMBI
RX
Yes
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TABLET;ORAL
125MG;100MG
2016-09-28
206038
ORKAMBI
RX
Yes
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GRANULE;ORAL
50MG/PACKET
2015-03-17
207925
KALYDECO
RX
Yes
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GRANULE;ORAL
75MG/PACKET
2015-03-17
207925
KALYDECO
RX
Yes
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GRANULE;ORAL
25MG/PACKET
2019-04-29
207925
KALYDECO
RX
Yes
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GRANULE;ORAL
5.8MG/PACKET
2023-05-03
207925
KALYDECO
RX
Yes
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GRANULE;ORAL
13.4MG/PACKET
2023-05-03
207925
KALYDECO
RX
Yes
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TABLET;ORAL
150MG;150MG, 100MG
2018-02-12
210491
SYMDEKO (COPACKAGED)
RX
Yes
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TABLET;ORAL
75MG;75MG, 50MG
2019-06-21
210491
SYMDEKO (COPACKAGED)
RX
Yes
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