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

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01 ABBVIE (3)

02 ALLERGAN (1)

03 SUN PHARM (3)

04 ALEMBIC (2)

05 AMPHASTAR PHARM (3)

06 APOTEX INC (4)

07 APOTHECON (2)

08 ASPIRO (2)

09 ATNAHS PHARMA US (1)

10 BAXTER HLTHCARE CORP (4)

11 BEDFORD (2)

12 BIONPHARMA (1)

13 CAPLIN (2)

14 CHARTWELL RX (3)

15 EPIC PHARMA LLC (2)

16 EUGIA PHARMA (4)

17 FRESENIUS KABI USA (4)

18 GLAND (2)

19 GLAND PHARMA LTD (3)

20 HETERO LABS LTD III (1)

21 HIKMA (8)

22 HOSPIRA (6)

23 LEADING (1)

24 LUITPOLD (2)

25 LUPIN LTD (1)

26 MICRO LABS LTD INDIA (1)

27 MYLAN (1)

28 NEPHRON (1)

29 PLIVA (1)

30 RAYNER SURGICAL (1)

31 ROCHE PALO (3)

32 SAGENT PHARMS INC (2)

33 SANDOZ (4)

34 SENORES PHARMS (1)

35 STERISCIENCE (4)

36 TEVA (1)

37 WATSON LABS (1)

38 WOCKHARDT (2)

39 WOCKHARDT BIO AG (1)

40 ZYDUS (1)

41 ZYLA (1)

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01 INJECTABLE; INJECTION (3)

02 INJECTABLE;INJECTION (59)

03 SOLUTION/DROPS;OPHTHALMIC (15)

04 SOLUTION;IRRIGATION (2)

05 SPRAY, METERED;NASAL (1)

06 TABLET;ORAL (13)

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01 DISCN (43)

02 RX (47)

03 Blank (3)

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01 ACULAR (1)

02 ACULAR LS (1)

03 ACULAR PRESERVATIVE FREE (1)

04 ACUVAIL (1)

05 KETOROLAC TROMETHAMINE (83)

06 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (1)

07 OMIDRIA (1)

08 SPRIX (1)

09 TORADOL (3)

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01 No (82)

02 Yes (8)

03 Blank (3)

URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
0.5%
1992-11-09
19700
ACULAR
RX
Yes
AT
Abbvie Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
0.5%
1997-11-03
20811
ACULAR PRESERVATIVE FR...
DISCN
No
Abbvie CB

EMWA 2024

Not Confirmed

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URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
0.4%
2003-05-30
21528
ACULAR LS
RX
Yes
AT
Abbvie Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
0.45%
2009-07-22
22427
ACUVAIL
RX
Yes
Abbvie Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
INJECTABLE;INJECTION
15MG/ML
2008-10-06
78737
KETOROLAC TROMETHAMINE
RX
No
AP
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INJECTABLE;INJECTION
30MG/ML
2008-10-06
78737
KETOROLAC TROMETHAMINE
RX
No
AP
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SOLUTION/DROPS;OPHTHALMIC
0.5%
2009-11-05
90017
KETOROLAC TROMETHAMINE
RX
No
AT
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TABLET;ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1991-12-20
19645
TORADOL
DISCN
Yes
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INJECTABLE;INJECTION
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1989-11-30
19698
TORADOL
DISCN
Yes
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INJECTABLE;INJECTION
30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1989-11-30
19698
TORADOL
DISCN
Yes
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