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

Client Email Product
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01 DR REDDYS (2)

02 AMNEAL (2)

03 AUROBINDO PHARMA LTD (2)

04 CIPLA (5)

05 CIPLA LTD (4)

06 HETERO LABS LTD III (4)

07 JANSSEN PRODS (9)

08 LUPIN LTD (6)

09 MSN (2)

10 MYLAN PHARMS INC (5)

11 TEVA PHARMS (1)

12 TEVA PHARMS USA (4)

13 ZYDUS PHARMS (4)

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01 SUSPENSION;ORAL (1)

02 TABLET; ORAL (5)

03 TABLET;ORAL (44)

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01 DISCN (2)

02 RX (24)

03 Blank (24)

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01 DARUNAVIR (41)

02 PREZCOBIX (1)

03 PREZISTA (7)

04 SYMTUZA (1)

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01 No (17)

02 Yes (9)

03 Blank (24)

URL Supplier Web Content
TABLET;ORAL
600MG
2023-11-28
211578
DARUNAVIR
RX
No
AB
URL Supplier Web Content
TABLET;ORAL
800MG
2023-11-28
211578
DARUNAVIR
RX
No
AB
URL Supplier Web Content
TABLET;ORAL
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2006-06-23
21976
PREZISTA
DISCN
Yes
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TABLET;ORAL
600MG
2008-02-25
21976
PREZISTA
RX
Yes
AB
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TABLET;ORAL
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-10-21
21976
PREZISTA
DISCN
Yes
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TABLET;ORAL
75MG
2008-12-18
21976
PREZISTA
RX
Yes
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TABLET;ORAL
150MG
2008-12-18
21976
PREZISTA
RX
Yes
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TABLET;ORAL
800MG
2012-11-09
21976
PREZISTA
RX
Yes
AB
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TABLET;ORAL
600MG
2022-09-29
202073
DARUNAVIR
RX
No
AB
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TABLET;ORAL
800MG
2022-09-29
202073
DARUNAVIR
RX
No
AB
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