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Approved Drug Products containing Prestwick2_000929 listed in the FDA Orange Book. Original Data : FDA Website

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01 3ABBVIE

02 1ALLERGAN

03 2ALEMBIC

04 3AMPHASTAR PHARM

05 4APOTEX INC

06 2APOTHECON

07 2ASPIRO

08 1ATNAHS PHARMA US

09 4BAXTER HLTHCARE CORP

10 2BEDFORD

11 1BIONPHARMA

12 3CAPLIN

13 3CHARTWELL RX

14 2EPIC PHARMA LLC

15 4EUGIA PHARMA

16 4FRESENIUS KABI USA

17 2GLAND

18 3GLAND PHARMA LTD

19 1HETERO LABS LTD III

20 8HIKMA

21 6HOSPIRA

22 1LEADING

23 2LUITPOLD

24 1LUPIN LTD

25 1MICRO LABS LTD INDIA

26 1MYLAN

27 1NEPHRON

28 1PLIVA

29 1RAYNER SURGICAL

30 3ROCHE PALO

31 2SAGENT PHARMS INC

32 4SANDOZ

33 1SENORES PHARMS

34 4STERISCIENCE SPECLTS

35 3SUN PHARM

36 1TEVA

37 1WATSON LABS

38 2WOCKHARDT

39 1WOCKHARDT BIO AG

40 1ZYDUS LIFESCIENCES

41 1ZYLA

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PharmaCompass

01

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KETOROLAC TROMETHAMINE

Brand Name : ACULAR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 1992-11-09

Application Number : 19700

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

Abbvie Company Banner

02

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KETOROLAC TROMETHAMINE

Brand Name : ACULAR PRESERVATIVE FREE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 1997-11-03

Application Number : 20811

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie CB

03

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KETOROLAC TROMETHAMINE

Brand Name : ACULAR LS

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.4%

Approval Date : 2003-05-30

Application Number : 21528

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

Abbvie Company Banner

04

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KETOROLAC TROMETHAMINE

Brand Name : ACUVAIL

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.45%

Approval Date : 2009-07-22

Application Number : 22427

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

05

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KETOROLAC TROMETHAMINE

Brand Name : SPRIX

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 15.75MG/SPRAY

Approval Date : 2010-05-14

Application Number : 22382

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

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KETOROLAC TROMETHAMINE

Brand Name : TORADOL

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-12-20

Application Number : 19645

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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KETOROLAC TROMETHAMINE

Brand Name : TORADOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1989-11-30

Application Number : 19698

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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KETOROLAC TROMETHAMINE

Brand Name : TORADOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1989-11-30

Application Number : 19698

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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KETOROLAC TROMETHAMINE

Brand Name : KETOROLAC TROMETHAMINE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1997-05-16

Application Number : 74754

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

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Not Confirmed

KETOROLAC TROMETHAMINE

Brand Name : KETOROLAC TROMETHAMINE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1997-05-16

Application Number : 74761

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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