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

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01 ALKEM LABS LTD (3)

02 APOTEX (2)

03 HETERO LABS LTD V (2)

04 MSN (2)

05 OTSUKA (8)

06 PAR PHARM INC (2)

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01 TABLET;ORAL (19)

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01 DISCN (1)

02 RX (18)

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01 JYNARQUE (5)

02 SAMSCA (3)

03 TOLVAPTAN (11)

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01 No (11)

02 Yes (8)

URL Supplier Web Content
TABLET;ORAL
30MG
2021-07-16
205646
TOLVAPTAN
RX
No
AB
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TABLET;ORAL
15MG
2022-09-06
205646
TOLVAPTAN
RX
No
AB
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TABLET;ORAL
15MG
2009-05-19
22275
SAMSCA
RX
Yes
AB
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TABLET;ORAL
30MG
2009-05-19
22275
SAMSCA
RX
Yes
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TABLET;ORAL
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2009-05-19
22275
SAMSCA
DISCN
Yes
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TABLET;ORAL
15MG
2018-04-23
204441
JYNARQUE
RX
Yes
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TABLET;ORAL
30MG
2018-04-23
204441
JYNARQUE
RX
Yes
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TABLET;ORAL
45MG
2018-04-23
204441
JYNARQUE
RX
Yes
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TABLET;ORAL
60MG
2018-04-23
204441
JYNARQUE
RX
Yes
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TABLET;ORAL
90MG
2018-04-23
204441
JYNARQUE
RX
Yes
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