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Approved Drug Products containing Tox21_202413 listed in the FDA Orange Book. Original Data : FDA Website

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01 2TARO

02 4STRIDES PHARMA

03 1ABBOTT

04 4ABLE

05 2ABRAXIS PHARM

06 5ALEMBIC

07 2ALEMBIC PHARMS LTD

08 1AMNEAL

09 2AUROBINDO PHARMA LTD

10 2B BRAUN

11 2BAUSCH

12 1BAXTER HLTHCARE

13 1BAXTER HLTHCARE CORP

14 2CADILA

15 2CADILA PHARMS LTD

16 1CASPER PHARMA LLC

17 2CHARTWELL MOLECULES

18 2CHARTWELL RX

19 1CHEMO RESEARCH SL

20 4COSETTE

21 4ENCUBE

22 1ENDO OPERATIONS

23 2FLAMINGO PHARMS

24 4FOSUN PHARMA

25 3FOUGERA PHARMS

26 4GALDERMA LABS LP

27 1GLAND PHARMA LTD

28 1GLENMARK PHARMS LTD

29 2HALSEY

30 2HERITAGE PHARMS INC

31 1HIKMA

32 1HOSPIRA

33 1INFORLIFE

34 2INNOGENIX

35 1INTL MEDICATION

36 2IVAX SUB TEVA PHARMS

37 2LABS AF

38 1LABS JUVISE

39 1LNK

40 2LUPIN LTD

41 2MUTUAL PHARM

42 1NOSTRUM LABS INC

43 2ORTHO MCNEIL PHARM

44 1PADAGIS ISRAEL

45 6PFIZER

46 1PLIVA

47 1RICONPHARMA LLC

48 1RISING

49 1SAPTALIS PHARMS

50 2SAVAGE LABS

51 1SOLARIS PHARMA CORP

52 2SUPERPHARM

53 1TEVA PHARMS

54 1TEVA PHARMS USA

55 2UNICHEM

56 7WATSON LABS

57 1WATSON LABS INC

58 1ZYDUS LIFESCIENCES

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1985-01-29

Application Number : 70039

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

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Not Confirmed

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.75%

Approval Date : 2006-07-18

Application Number : 77819

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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Not Confirmed

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : GEL;TOPICAL

Dosage Strength : 1%

Approval Date : 2017-03-14

Application Number : 204651

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 1985-01-29

Application Number : 70040

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2016-05-25

Application Number : 208162

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

METRONIDAZOLE

Brand Name : METRONIDAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2016-05-25

Application Number : 208162

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

07

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Not Confirmed
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Not Confirmed

METRONIDAZOLE

Brand Name : FLAGYL

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 12623

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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Not Confirmed
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Not Confirmed

METRONIDAZOLE

Brand Name : FLAGYL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 12623

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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Not Confirmed
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METRONIDAZOLE HYDROCHLORIDE

Brand Name : FLAGYL I.V.

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18353

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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Not Confirmed
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Not Confirmed

METRONIDAZOLE

Brand Name : FLAGYL I.V. RTU IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/100ML

Approval Date : 1982-01-01

Application Number : 18353

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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