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BROMOCRIPTINE MESYLATE

ANDA

BROMOCRIPTINE MESYLATE | A075100 | LEK PHARMACEUTICAL AND CHEMICAL CO DD

1 strength0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 10, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 10, 1998

No patent or exclusivity listings for this strength.