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

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01 3MIKART

02 2STRIDES PHARMA

03 2ACELLA

04 3ASCENT PHARMS INC

05 2BIONPHARMA

06 3CHARTWELL RX

07 2CSPC-NBP PHARM

08 2HERITAGE PHARMS LABS

09 2NESHER PHARMS

10 2PFIZER

11 2PURACAP PHARM LLC

12 2SUN PHARM INDS INC

13 5THEPHARMANETWORK LLC

14 2ZYDUS PHARMS USA

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

RLD : No

TE Code :

BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2009-11-09

Application Number : 40851

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

02

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AA

BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2015-07-30

Application Number : 91133

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

RLD : No

TE Code :

BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date : 2009-11-09

Application Number : 40851

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAs a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

RLD : No

TE Code :

BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2009-11-09

Application Number : 40851

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

05

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AA

BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2015-07-30

Application Number : 91133

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

06

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BENZONATATE

Brand Name : TESSALON

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1982-01-01

Application Number : 11210

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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07

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BENZONATATE

Brand Name : TESSALON

Dosage Form : CAPSULE;ORAL

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

Approval Date : 1999-06-25

Application Number : 11210

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2008-03-19

Application Number : 40587

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2008-03-19

Application Number : 40587

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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BENZONATATE

Brand Name : BENZONATATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2007-06-08

Application Number : 40597

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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