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Approved Drug Products of Organon listed in the FDA Orange Book. Original Data : FDA Website

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Organon
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Country
U.S.A
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Address
30 Hudson Street, Jersey City, NJ 07302
Telephone
Telephone
551-430-6000
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URL Supplier Web Content
TABLET; ORAL
EQ 10MG BASE **Fed...
1995-09-29
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 40MG BASE **Fed...
1995-09-29
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 5MG BASE **Fede...
1997-04-25
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 35MG BASE **Fed...
2000-10-20
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 70MG BASE
2000-10-20
20560
FOSAMAX
RX
Yes
AB
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TABLET; ORAL
EQ 70MG BASE;2,800...
2005-04-07
21762
FOSAMAX PLUS D
RX
Yes
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TABLET; ORAL
EQ 70MG BASE;5,600...
2007-04-26
21762
FOSAMAX PLUS D
RX
Yes
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TABLET; ORAL
EQ 10MG BASE;10MG ...
2013-05-03
200153
LIPTRUZET
DISCN
Yes
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TABLET; ORAL
EQ 20MG BASE;10MG ...
2013-05-03
200153
LIPTRUZET
DISCN
Yes
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TABLET; ORAL
EQ 40MG BASE;10MG ...
2013-05-03
200153
LIPTRUZET
DISCN
Yes
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TABLET; ORAL
EQ 80MG BASE;10MG ...
2013-05-03
200153
LIPTRUZET
DISCN
Yes
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INJECTABLE; INJECT...
3MG/ML;EQ 3MG BASE...
1982-01-01
14602
CELESTONE SOLUSPAN
RX
Yes
AB
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OINTMENT, AUGMENTE...
EQ 0.05% BASE
1983-07-27
18741
DIPROLENE
RX
Yes
AB
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CREAM, AUGMENTED; ...
EQ 0.05% BASE **Fe...
1987-04-27
19555
DIPROLENE AF
DISCN
Yes
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LOTION, AUGMENTED;...
EQ 0.05% BASE **Fe...
1988-08-01
19716
DIPROLENE
DISCN
Yes
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CREAM; TOPICAL
EQ 0.05% BASE;1%
1984-07-10
18827
LOTRISONE
DISCN
Yes
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TABLET; ORAL
10MG;100MG
1982-01-01
17555
SINEMET
RX
Yes
AB
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TABLET; ORAL
25MG;250MG
1982-01-01
17555
SINEMET
RX
Yes
AB
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TABLET; ORAL
25MG;100MG
1982-01-01
17555
SINEMET
RX
Yes
AB
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TABLET, EXTENDED R...
50MG;200MG **Feder...
1991-05-30
19856
SINEMET CR
DISCN
Yes
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TABLET, EXTENDED R...
25MG;100MG **Feder...
1992-12-24
19856
SINEMET CR
DISCN
Yes
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GEL; VAGINAL
EQ 2% BASE
2021-12-07
215650
XACIATO
RX
Yes
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TABLET; ORAL
5MG
2001-12-21
21165
CLARINEX
RX
Yes
AB
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TABLET, ORALLY DIS...
5MG **Federal Regi...
2002-06-26
21312
CLARINEX
DISCN
Yes
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TABLET, ORALLY DIS...
2.5MG **Federal Re...
2005-07-14
21312
CLARINEX
DISCN
Yes
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TABLET, EXTENDED R...
2.5MG;120MG
2006-02-01
21313
CLARINEX-D 12 HOUR
RX
Yes
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TABLET, EXTENDED R...
5MG;240MG **Federa...
2005-03-03
21605
CLARINEX D 24 HOUR
DISCN
Yes
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RING; VAGINAL
0.015MG/24HR;0.12M...
2001-10-03
21187
NUVARING
RX
Yes
AB
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IMPLANT; IMPLANTAT...
68MG/IMPLANT
2006-07-17
21529
IMPLANON
DISCN
No
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IMPLANT; IMPLANTAT...
68MG/IMPLANT
2011-05-13
21529
NEXPLANON
RX
Yes
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TABLET; ORAL
10MG
2002-10-25
21445
ZETIA
RX
Yes
AB
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TABLET; ORAL
10MG;10MG
2004-07-23
21687
VYTORIN
RX
Yes
AB
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TABLET; ORAL
10MG;20MG
2004-07-23
21687
VYTORIN
RX
Yes
AB
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TABLET; ORAL
10MG;40MG
2004-07-23
21687
VYTORIN
RX
Yes
AB
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TABLET; ORAL
10MG;80MG
2004-07-23
21687
VYTORIN
RX
Yes
AB
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TABLET; ORAL
5MG
1992-06-19
20180
PROSCAR
RX
Yes
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TABLET; ORAL
1MG
1997-12-19
20788
PROPECIA
RX
Yes
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AEROSOL, METERED; ...
0.005MG/INH;0.1MG/...
2010-06-22
22518
DULERA
RX
Yes
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AEROSOL, METERED; ...
0.005MG/INH;0.2MG/...
2010-06-22
22518
DULERA
RX
Yes
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AEROSOL, METERED; ...
0.005MG/INH;0.05MG...
2019-08-12
22518
DULERA
RX
Yes
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INJECTABLE; INJECT...
250MCG/0.5ML
1999-07-29
21057
GANIRELIX ACETATE
RX
Yes
AP
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TABLET; ORAL
12.5MG;50MG
1995-04-28
20387
HYZAAR
RX
Yes
AB
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TABLET; ORAL
25MG;100MG
1998-11-10
20387
HYZAAR
RX
Yes
AB
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TABLET; ORAL
12.5MG;100MG
2005-10-20
20387
HYZAAR
RX
Yes
AB
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TABLET; ORAL
25MG
1995-04-14
20386
COZAAR
RX
Yes
AB
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TABLET; ORAL
50MG
1995-04-14
20386
COZAAR
RX
Yes
AB
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TABLET; ORAL
100MG
1998-10-13
20386
COZAAR
RX
Yes
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TABLET; ORAL
15MG
1996-06-14
20415
REMERON
RX
Yes
AB
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TABLET; ORAL
30MG
1996-06-14
20415
REMERON
RX
Yes
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TABLET; ORAL
45MG **Federal Reg...
1997-03-17
20415
REMERON
DISCN
Yes
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