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

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01 3ABBVIE

02 1TARO

03 2BRECKENRIDGE

04 12STRIDES PHARMA

05 9GRANULES

06 13ABBOTT

07 6ABRAXIS PHARM

08 4ACTAVIS LABS FL INC

09 4ADARE PHARMS INC

10 2ALCON

11 1ALCON PHARMS LTD

12 6AMNEAL

13 1AMNEAL PHARMS

14 2ANDA REPOSITORY

15 2APOTEX

16 1APOTHECON

17 3ASCENT PHARMS INC

18 2AUROBINDO PHARMA

19 3AUROBINDO PHARMA LTD

20 1AUROBINDO PHARMA USA

21 123B BRAUN

22 78BAXTER HLTHCARE

23 17BAXTER HLTHCARE CORP

24 3BELCHER

25 6BRAINTREE

26 2BRAINTREE LABS

27 2CHARTWELL MOLECULAR

28 4CHARTWELL RX

29 1COPLEY PHARM

30 1DYNAPHARM

31 1E Z EM

32 1ELAN PHARM

33 2ENDO OPERATIONS

34 4EPIC PHARMA LLC

35 1ESI LEDERLE

36 2EXTROVIS

37 37FRESENIUS KABI USA

38 2FUTURE PAK

39 6GD SEARLE LLC

40 3GENUS

41 2GENUS LIFESCIENCES

42 3GLENMARK PHARMS LTD

43 1GOLDLINE

44 2GUANGZHOU NOVAKEN

45 14HOSPIRA

46 10HOSPIRA INC

47 71ICU MEDICAL INC

48 1INTL MEDICATION

49 1KV PHARM

50 1L PERRIGO CO

51 1LILLY

52 4LUITPOLD

53 1LUKARE MEDICAL LLC

54 2LUPIN LTD

55 5MACLEODS PHARMS LTD

56 6MILES

57 2MYLAN

58 4NESHER PHARMS

59 5NEXUS

60 1NEXUS PHARMS

61 8NORVIUM BIOSCIENCE

62 1NOSTRUM LABS INC

63 2NOVARTIS

64 15NOVEL LABS INC

65 1NOVITIUM PHARMA

66 4PADAGIS US

67 2PADDOCK LLC

68 2PHARM ASSOC

69 2PHARMA SERVE NY

70 5PRINSTON INC

71 2RISING PHARMA

72 9RUBICON

73 1SALIX

74 1SALIX PHARMS

75 1SANDOZ

76 4SAVAGE LABS

77 2SCHERING

78 2SCIEGEN PHARMS INC

79 2SIGMAPHARM LABS LLC

80 2TEVA

81 4TRIS PHARMA INC

82 2TWI PHARMS

83 8UPSHER SMITH LABS

84 2VINTAGE PHARMS

85 4WATSON LABS

86 2WES PHARMA INC

87 4YICHANG HUMANWELL

88 4ZYDUS PHARMS

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PharmaCompass

01

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Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

02

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Formnext Forum
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ

Approval Date : 2020-08-21

Application Number : 213588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AA

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Brand Name : POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT

Approval Date : 2018-12-21

Application Number : 204558

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB2

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ

Approval Date : 2020-03-04

Application Number : 211797

RX/OTC/DISCN : RX

RLD : No

TE Code : AB2

Granules India

05

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Formnext Forum
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-08-01

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

06

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Formnext Forum
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2013-11-25

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

07

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Not Confirmed

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Brand Name : PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date : 2024-06-28

Application Number : 207498

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

blank

08

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Formnext Forum
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MEQ

Approval Date : 2020-08-21

Application Number : 213588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

09

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AA

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Brand Name : PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

Approval Date : 2015-04-13

Application Number : 204559

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

10

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ

Approval Date : 2015-12-08

Application Number : 205549

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science