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Approved Drug Products containing Tox21_300395 listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS

02 3DR REDDYS LABS SA

03 4TARO

04 2ACELLA

05 1AUROBINDO PHARMA LTD

06 3BAXTER HLTHCARE

07 1BEDFORD

08 1BEDFORD LABS

09 1BEN VENUE

10 3CHARTWELL RX

11 1EPIC PHARMA LLC

12 1EUGIA PHARMA

13 1FRESENIUS KABI USA

14 1GLAND PHARMA LTD

15 1HIKMA FARMACEUTICA

16 4HOSPIRA

17 1INTL MEDICATION SYS

18 1MYLAN INSTITUTIONAL

19 1NORVIUM BIOSCIENCE

20 1PAR STERILE PRODUCTS

21 3RUBICON

22 1TEVA

23 1TEVA PHARMS

24 1UNICHEM

25 5UPSHER SMITH LABS

26 1WYETH PHARMS

27 1WYETH PHARMS INC

28 1ZHEJIANG POLY PHARM

29 3ZYDUS PHARMS USA INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2001-01-25

Application Number : 75389

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2017-12-28

Application Number : 75389

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2017-12-28

Application Number : 75389

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/ML

Approval Date : 2003-09-05

Application Number : 76163

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

05

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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2001-03-30

Application Number : 75424

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2002-12-18

Application Number : 75424

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2002-11-29

Application Number : 76362

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : AMIODARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 300MG

Approval Date : 2003-12-02

Application Number : 76362

RX/OTC/DISCN : RX

RLD : No

TE Code :

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09

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Not Confirmed
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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : CORDARONE

Dosage Form : TABLET;ORAL

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

Approval Date : 1985-12-24

Application Number : 18972

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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Not Confirmed
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Not Confirmed

AMIODARONE HYDROCHLORIDE

Brand Name : CORDARONE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-08-03

Application Number : 20377

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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