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01 1STRIDES PHARMA

02 1AAIPHARMA LLC

03 1ALMIRALL

04 1AUROBINDO PHARMA USA

05 1CHARTWELL RX

06 1COSETTE

07 1ENCUBE

08 1FOUGERA PHARMS

09 1HERITAGE PHARMA

10 2JANSSEN PHARMA

11 2JANSSEN PHARMS

12 1KRAMER

13 1NORVIUM BIOSCIENCE

14 1NOVITIUM PHARMA

15 2PADAGIS ISRAEL

16 1SENORES PHARMS

17 1SUN PHARM INDUSTRIES

18 2TARO

19 2TEVA

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PharmaCompass

01

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

KETOCONAZOLE

Brand Name : KETOCONAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2018-06-18

Application Number : 210457

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : XOLEGEL

Dosage Form : GEL;TOPICAL

Dosage Strength : 2%

Approval Date : 2006-07-28

Application Number : 21946

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : KETOCONAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 1999-06-15

Application Number : 74971

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : NIZORAL

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18533

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : NIZORAL

Dosage Form : CREAM;TOPICAL

Dosage Strength : 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1985-12-31

Application Number : 19084

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : NIZORAL

Dosage Form : SHAMPOO;TOPICAL

Dosage Strength : 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1990-08-31

Application Number : 19927

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : NIZORAL

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 100MG/5ML

Approval Date : 1986-11-07

Application Number : 70767

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : NIZORAL ANTI-DANDRUFF

Dosage Form : SHAMPOO;TOPICAL

Dosage Strength : 1%

Approval Date : 1997-10-10

Application Number : 20310

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : KETOCONAZOLE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 1999-06-15

Application Number : 75273

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

NORVIUM BIOSCIENCE

Country
Antibody Engineering
Not Confirmed
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NORVIUM BIOSCIENCE

Country
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Antibody Engineering
Not Confirmed

KETOCONAZOLE

Brand Name : EXTINA

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 2%

Approval Date : 2007-06-12

Application Number : 21738

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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