MedPath
FDA Approval

BROMOCRIPTINE MESYLATE

February 6, 2020

HUMAN PRESCRIPTION DRUG LABEL

Bromocriptine(5 mg in 1 1)

Manufacturing Establishments (1)

Halo Pharmaceutical Inc

Sun Pharmaceutical Industries, Inc.

829609168

Products (2)

BROMOCRIPTINE MESYLATE

63304-158

NDA017962

NDA (C73594)

ORAL

February 6, 2020

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
Code: FFP983J3ODClass: ACTIMQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

BROMOCRIPTINE MESYLATE

63304-962

NDA017962

NDA (C73594)

ORAL

February 6, 2020

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Code: FFP983J3ODClass: ACTIMQuantity: 2.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MALEIC ACIDInactive
Code: 91XW058U2CClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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