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FDA Drug information

Dihydroergotamine Mesylate

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Adverse Reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Effective Time

20230317

Version

1

Spl Product Data Elements

Dihydroergotamine Mesylate Dihydroergotamine Mesylate DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE GLYCERIN ALCOHOL METHANESULFONIC ACID SODIUM HYDROXIDE WATER

Application Number

ANDA040453

Brand Name

Dihydroergotamine Mesylate

Generic Name

Dihydroergotamine Mesylate

Product Ndc

62778-336

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR,INTRAVENOUS,SUBCUTANEOUS

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL NDC 0143- 9151 -01 Rx only Dihydroergotamine Mesylate Injection, USP 1 mg/mL For IV, IM or SC Use ONLY 1 mL Single-Dose Vial NDC 0143- 9151 -10 Rx only Dihydroergotamine Mesylate Injection, USP 1 mg/mL For Intramuscular, Intravenous or Subcutaneous Use ONLY 10 x 1 mL Single-Dose Vials vial label Carton

Drug section

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