apomorphine hydrocloride
These highlights do not include all the information needed to use APOMORPHINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for APOMORPHINE HYDROCHLORIDE INJECTION. APOMORPHINE HYDROCHLORIDE injection, for subcutaneous use Initial U.S. Approval: 2004
Approved
Approval ID
aedf70e4-1949-44bc-bf1b-0f282c4f0705
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2022
Manufacturers
FDA
TruPharma, LLC
DUNS: 078533947
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
APOMORPHINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-720
Application NumberANDA212025
Product Classification
M
Marketing Category
C73584
G
Generic Name
APOMORPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (6)
APOMORPHINE HYDROCHLORIDEActive
Quantity: 30 mg in 3 mL
Code: F39049Y068
Classification: ACTIB
sodium metabisulfiteInactive
Quantity: 3 mg in 3 mL
Code: 4VON5FNS3C
Classification: IACT
benzyl alcoholInactive
Quantity: 15 mg in 3 mL
Code: LKG8494WBH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT