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PARLODEL

NDA

BROMOCRIPTINE MESYLATE | N017962 | ESJAY PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 inactive

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

LEK PHARMACEUTICALS DDBROMOCRIPTINE MESYLATE USP

DMF 68271987

CURIA ITALY SRLBROMOCRIPTINE MESYLATE

DMF 69551987

TAPI NL BVBROMOCRIPTINE MESYLATE

DMF 147682000

GEDEON RICHTER LTDInactiveBROMOCRIPTINE MESYLATE USP

DMF 67371986

CHEMAPOL LTDInactiveBROMOCRIPTINE MESYLATE

DMF 69841987

LABOCHIMInactiveBROMOCRIPTINE MESYLATE

DMF 70881987

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveBROMOCRIPTINE MESYLATE

DMF 106791993

GALENA ASInactiveBROMOCRIPTINE MESYLATE

DMF 119731996

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

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 2.5MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 1, 1982