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SOLIFENACIN SUCCINATE

ANDA

SOLIFENACIN SUCCINATE | A213346 | SUNSHINE LAKE PHARMA CO LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain25 active DMFs7 inactive

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

TAPI NL BVSOLIFENACIN SUCCINATE

DMF 221732008

DR REDDYS LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 222632008

ALIVUS LIFE SCIENCES LTDSOLIFENACIN SUCCINATE

DMF 224182009

MSN LABORATORIES PRIVATE LTDSOLIFENACIN SUCCINATE [ROUTE CODE - "SF"]

DMF 237472010

UNIMARK REMEDIES LTDSOLIFENACIN SUCCINATE

DMF 239652010

INTERQUIM SASOLIFENACIN SUCCINATE

DMF 241542010

MEGAFINE PHARMA P LTDSOLIFENACIN SUCCINATE

DMF 241862010

JUBILANT BIOSYS LTDSOLIFENACIN SUCCINATE

DMF 247652011

HETERO DRUGS LTDSOLIFENACIN SUCCINATE

DMF 248712011

ALEMBIC PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 258872012

APITORIA PHARMA PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 275502013

WEIHAI DISU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE

DMF 283732015

ISOCHEM SASSOLIFENACIN SUCCINATE

DMF 288702014

CIPLA LTDSOLIFENACIN SUCCINATE

DMF 294892015

QILU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE (NON-STERILE, API)

DMF 295032015

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)SOLIFENACIN SUCCINATE

DMF 295812015

UNICHEM LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 303832016

RAKS PHARMA PVT LTDSOLIFENACIN SUCCINATE

DMF 305412016

DELMAR CHEMICALS INCSOLIFENACIN SUCCINATE

DMF 306712016

OPTIMUS DRUGS PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 309652016

MICRO LABS LTDSOLIFENACIN SUCCINATE

DMF 314592017

AMOLI ORGANICS PVT LTDSOLIFENACIN SUCCINATE

DMF 317892017

NOVUGEN PHARMA MALAYSIA SDN BHDSOLIFENACIN SUCCINATE

DMF 333062019

RUYUAN HEC PHARM CO LTDSOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE

DMF 351402020

SMS PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 361332022

CADILA HEALTHCARE LTDInactiveSOLIFENACIN SUCCINATE

DMF 236892010

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveSOLIFENACIN SUCCINATE

DMF 240442010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSOLIFENACIN SUCCINATE

DMF 244472010

PHF SAInactiveSOLIFENACIN SUCCINATE

DMF 254882011

CRYSTAL PHARMA LTDInactiveSOLIFENACIN SUCCINATE

DMF 261252012

FIS FABBRICA ITALIANA SINTETICI SPAInactiveSOLIFENACIN SUCCINATE

DMF 261902012

KYONGBO PHARMACEUTICAL CO LTDInactiveSOLIFENACIN SUCCINATE

DMF 289772015

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

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 13, 2020

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2020

Change History (4)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Sunshine's solifenacin succinate application (NDA 213346, supplement 002) changed status from discontinued to active prescription drug.

Old: DISCN

New: RX

MODIFIEDtype7/1/2026

Sunshine's solifenacin succinate oral solution (NDA 213346) status changed from discontinued to active prescription drug.

Old: DISCN

New: RX

MODIFIEDTE Code7/1/2026

Solifenacin Succinate (Sunshine, NDA 213346) received an AB therapeutic equivalence rating, indicating bioequivalence to the reference product.

New: AB

MODIFIEDTE Code7/1/2026

Solifenacin Succinate (Sunshine) received an AB therapeutic equivalence rating, indicating bioequivalence to the reference product and eligibility for generic substitution.

New: AB