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

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01 TARO (3)

02 ACTAVIS ELIZABETH (3)

03 ACTAVIS LABS FL INC (2)

04 ACTAVIS LABS UT INC (1)

05 ACTAVIS MID ATLANTIC (1)

06 ALEMBIC (2)

07 ALTAIRE PHARMS INC (1)

08 AMNEAL (2)

09 AMNEAL PHARMS (4)

10 APOTEX (2)

11 AUROBINDO PHARMA USA (3)

12 AUROLIFE PHARMA LLC (2)

13 BAUSCH AND LOMB (1)

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17 DEXCEL LTD (1)

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19 EPIC PHARMA LLC (1)

20 EXELA HOLDINGS (2)

21 FALCON PHARMS (1)

22 FOUGERA PHARMS (1)

23 GLENMARK PHARMS LTD (1)

24 HALEON US HOLDINGS (1)

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27 JAVELIN PHARMS INC (1)

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30 MICRO LABS (4)

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55 ZYDUS PHARMS (2)

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01 GEL;TOPICAL (14)

02 SOLUTION/DROPS;OPHTHALMIC (8)

03 SOLUTION;INTRAVENOUS (2)

04 SOLUTION;TOPICAL (22)

05 TABLET, DELAYED RELEASE;ORAL (47)

06 TABLET, EXTENDED RELEASE;ORAL (6)

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01 DISCN (40)

02 OTC (5)

03 RX (51)

04 Blank (3)

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01 ARTHROTEC (2)

02 DICLOFENAC SODIUM (73)

03 DICLOFENAC SODIUM AND MISOPROSTOL (14)

04 DYLOJECT (1)

05 PENNSAID (2)

06 SOLARAZE (1)

07 VOLTAREN (4)

08 VOLTAREN ARTHRITIS PAIN (1)

09 VOLTAREN-XR (1)

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01 No (84)

02 Yes (12)

03 Blank (3)

URL Supplier Web Content
SOLUTION;TOPICAL
1.5%
2014-11-26
203818
DICLOFENAC SODIUM
RX
No
AT
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GEL;TOPICAL
3%
2016-04-28
206298
DICLOFENAC SODIUM
RX
No
AB
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SOLUTION;TOPICAL
2%
2022-09-29
208098
DICLOFENAC SODIUM
RX
No
AB
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TABLET, DELAYED RELEASE;ORAL
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1988-07-28
19201
VOLTAREN
DISCN
Yes
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TABLET, DELAYED RELEASE;ORAL
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1988-07-28
19201
VOLTAREN
DISCN
Yes
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TABLET, DELAYED RELEASE;ORAL
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1988-07-28
19201
VOLTAREN
DISCN
Yes
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SOLUTION/DROPS;OPHTHALMIC
0.1%
1991-03-28
20037
VOLTAREN
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-03-08
20254
VOLTAREN-XR
DISCN
Yes
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TABLET, DELAYED RELEASE;ORAL
50MG;0.2MG
1997-12-24
20607
ARTHROTEC
RX
Yes
AB
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TABLET, DELAYED RELEASE;ORAL
75MG;0.2MG
1997-12-24
20607
ARTHROTEC
RX
Yes
AB
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