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

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01 1MISSION PHARMA

02 2MISSION PHARMACAL

03 1AMNEAL

04 3ENDO OPERATIONS

05 2TEVA PHARMS INC

06 1TEVA PHARMS USA INC

07 2TORRENT

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01

  • fda
  • EDQM
  • WHO-GMP

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RLD : Yes

TE Code : AB

TIOPRONIN

Brand Name : THIOLA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 1988-08-11

Application Number : 19569

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Mission Pharmacal

02

  • fda
  • EDQM
  • WHO-GMP

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RLD : Yes

TE Code : AB

TIOPRONIN

Brand Name : THIOLA EC

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 100MG

Approval Date : 2019-06-28

Application Number : 211843

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Mission Pharmacal

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

RLD : Yes

TE Code : AB

TIOPRONIN

Brand Name : THIOLA EC

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date : 2019-06-28

Application Number : 211843

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Mission Pharmacal

04

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date : 2023-08-15

Application Number : 216278

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 100MG

Approval Date : 2024-07-22

Application Number : 216456

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date : 2024-07-22

Application Number : 216456

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2021-04-26

Application Number : 214326

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 100MG

Approval Date : 2024-01-30

Application Number : 216990

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 300MG

Approval Date : 2024-01-30

Application Number : 216990

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

ENDO OPERATIONS

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ENDO OPERATIONS

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TIOPRONIN

Brand Name : TIOPRONIN

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2022-06-02

Application Number : 216198

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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