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FDA Drug information

Bromocriptine mesylate

Read time: 1 mins
Marketing start date: 04 May 2024
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Summary of product characteristics


Effective Time

20220804

Version

9

Spl Product Data Elements

Bromocriptine mesylate Bromocriptine mesylate BROMOCRIPTINE MESYLATE BROMOCRIPTINE ALCOHOL AMMONIA BUTYL ALCOHOL CARRAGEENAN FERRIC OXIDE RED FERROSOFERRIC OXIDE HYPROMELLOSE 2910 (15 MPA.S) ISOPROPYL ALCOHOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALEIC ACID POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE TITANIUM DIOXIDE WATER TAN WHITE CAPSULE ZA17;5mg

Application Number

ANDA078899

Brand Name

Bromocriptine mesylate

Generic Name

Bromocriptine mesylate

Product Ndc

65841-654

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-654-01 in bottle of 100 Capsules Bromocriptine Mesylate Capsules USP, 5 mg R x only 100 Capsules bromocriptine mesylate capsules, 5 mg

Drug section

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