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TOPIRAMATE

ANDA

TOPIRAMATE | A206210 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TROKENDI XR(TE code: AB1)

API Supply Chain19 active DMFs11 inactive

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

JANSSEN PHARMACEUTICA NVTOPIRAMATE DRUG SUBSTANCE

DMF 109191994

CIPLA LTDTOPIRAMATE USP

DMF 156932001

DR REDDYS LABORATORIES LTDTOPIRAMATE USP

DMF 165332003

SCINOPHARM TAIWAN LTDTOPIRAMATE USP

DMF 170352003

ALIVUS LIFE SCIENCES LTDTOPIRAMATE USP

DMF 177292004

SUN PHARMACEUTICAL INDUSTRIES LTDTOPIRAMATE USP

DMF 181722005

HETERO DRUGS LTDTOPIRAMATE

DMF 183462005

ZYDUS LIFESCIENCES LTDTOPIRAMATE USP

DMF 187002005

APITORIA PHARMA PRIVATE LTDTOPIRAMATE USP

DMF 192472006

TORRENT PHARMACEUTICALS LTDTOPIRAMATE

DMF 203862007

ZAKLADY FARMACEUTYCZNE POLPHARMA SATOPIRAMATE

DMF 205812007

UNIMARK REMEDIES LTDTOPIRAMATE USP

DMF 209322007

UNIMARK REMEDIES LTDTOPIRAMATE USP (PROCESS A)

DMF 233492009

MSN ORGANICS PRIVATE LTDTOPIRAMATE USP [ROUTE CODE - "TI"]

DMF 257132012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 283712014

UNICHEM LABORATORIES LTDTOPIRAMATE USP

DMF 351912020

GLOBAL CALCIUM PRIVATE LTDTOPIRAMATE USP

DMF 396362024

HUADONG MEDICINE (XI'AN) BODYGUARD PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 408292024

SNJ LIFECARE PVT LTDTOPIRAMATE USP

DMF 420322025

CILAG AGInactiveTOPIRAMATE

DMF 109781994

FERRO PFANSTIEHL LABORATORIES INCInactiveTOPIRAMATE

DMF 156582001

ALKALOIDA CHEMICAL CO ZRTInactiveTOPIRAMATE

DMF 164052003

CF PHARMA LTDInactiveTOPIRAMATE

DMF 182692005

LUPIN LTDInactiveTOPIRAMATE USP

DMF 193252006

DIVIS LABORATORIES LTDInactiveTOPIRAMATE

DMF 210682007

SIGNA SA DE CVInactiveTOPIRAMATE USP

DMF 216572008

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE

DMF 227452009

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE USP

DMF 248332011

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE USP

DMF 269192013

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE

DMF 274392013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 20, 2023	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG

AB1

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 10, 2023

No patent or exclusivity listings for this strength.

#002 — 50MG

AB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 10, 2023

#003 — 100MG

AB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 10, 2023

#004 — 200MG

AB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 10, 2023