Viewing data from:

SPIRONOLACTONE

ANDA

SPIRONOLACTONE | A215572 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CAROSPIR(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CMP Development, LLC v. Amneal Pharmaceuticals LLC 1:2021cv00549 5 patentsANDA 215572spironolactone	D. Del.	2021-04-16	Terminated 2023-10-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain9 active DMFs9 inactive

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

GEDEON RICHTER PLCSPIRONOLACTONE USP

DMF 140771999

EUROAPI FRANCESPIRONOLACTONE

DMF 172642004

TIANJIN TIANYAO PHARMACEUTICALS CO LTDSPIRONOLACTONE USP BULK

DMF 182382005

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 202862007

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 268812013

TIANJIN JINJIN PHARMACEUTICAL CO LTDSPIRONOLACTONE USP BULK API

DMF 301922015

HUBEI GOTO BIOTECHNOLOGY CO LTDSPIRONOLACTONE

DMF 323702018

DASAMI LAB PRIVATE LTDSPIRONOLACTONE USP

DMF 366782022

NORTEC QUIMICA SASPIRONOLACTONE

DMF 377082024

ANTIBIOTICOS SPAInactiveSPIRONOLACTONE

DMF 26571976

DIPHARMA FRANCIS SRLInactiveSPIRONOLACTONE

DMF 30521977

SCHERING AGInactiveSPIRONOLACTONE

DMF 33321978

MEDIMPEX NORTHAMERICA INCInactiveSPIRONOLACTONE USP XIX

DMF 33431978

BOEHRINGER MANNHEIM GMBHInactiveSPIRONOLACTONE (BULK FORM) USP XIX, BP 1973

DMF 33501978

DIOSYNTH BVInactiveSPIRONOLACTONE MICRO

DMF 37181980

OLON SPAInactiveSPIRONOLACTONE

DMF 185462005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveSPIRONOLACTONE

DMF 198592006

PIRAMAL HEALTHCARE UK LTDInactiveSPIRONOLACTONE USP

DMF 254962012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Sep 5, 2023

No patent or exclusivity listings for this strength.