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Approved Drug Products containing MolPort-001-783-551 listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS

02 2ADIENNE SA

03 2BELOTECA

04 1FRESENIUS KABI USA

05 2GLAND PHARMA LTD

06 1HENGRUI PHARMA

07 1HIKMA

08 2IMMUNEX

09 2MEITHEAL

10 2MSN

11 1PENN LIFE

12 1SHORLA

13 2TEVA PARENTERAL

14 1WEST-WARD PHARMS INT

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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 : AP

THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL

Approval Date : 2018-05-04

Application Number : 210337

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

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THIOTEPA

Brand Name : TEPADINA

Dosage Form : POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL

Dosage Strength : 15MG/VIAL

Approval Date : 2017-01-26

Application Number : 208264

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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03

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THIOTEPA

Brand Name : TEPADINA

Dosage Form : POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL

Dosage Strength : 100MG/VIAL

Approval Date : 2017-01-26

Application Number : 208264

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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04

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL

Approval Date : 1982-01-01

Application Number : 11683

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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THIOTEPA

Brand Name : THIOPLEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-12-22

Application Number : 20058

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL

Approval Date : 2001-09-20

Application Number : 75698

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL

Approval Date : 2020-01-10

Application Number : 208242

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-04-20

Application Number : 75730

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-04-20

Application Number : 75730

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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THIOTEPA

Brand Name : THIOTEPA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 15MG/VIAL

Approval Date : 2001-04-02

Application Number : 75547

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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