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THIOTEPA

ANDA

THIOTEPA | A213049 | MSN LABORATORIES PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TEPADINA(TE code: AP)

API Supply Chain7 active DMFs6 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

HERAEUS PRECIOUS METALS GMBH AND CO KGTHIOTEPA USP

DMF 139111998

IDT AUSTRALIA LTDTHIOTEPA USP

DMF 141701999

MSN LABORATORIES PRIVATE LTDTHIOTEPA USP [ROUTE CODE "ZT"]

DMF 304242016

NATCO PHARMA LTDTHIOTEPA

DMF 311042017

EMCURE PHARMACEUTICALS LTDTHIOTEPA USP

DMF 327462018

INDENA SPATHIOTEPA

DMF 330372019

SEACROSS PHARMA USA INCTHIOTEPA

DMF 384062023

SUMIKA FINE CHEMICALS CO LTDInactiveTHIOTEPA USP XX

DMF 53961984

SOGO PHARMACEUTICAL CO LTDInactiveTHIOTEPA

DMF 75181988

ICI COLOURS AND FINE CHEMSInactiveTHIOTEPA

DMF 82281989

JIANGSU HENGRUI MEDICINE CO LTDInactiveTHIOTEPA USP NON STERILE BULK DRUG

DMF 143161999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTHIOTEPA

DMF 145121999

MYLAN LABORATORIES LTDInactiveTHIOTEPA USP

DMF 263832012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 15, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Approved: Mar 4, 2020

No patent or exclusivity listings for this strength.

#002 — 100MG/VIAL

0 patents0 exclusivities▾

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Approved: Mar 4, 2020