MedPath

Savella

These highlights do not include all the information needed to use Savella safely and effectively. See full prescribing information for Savella.    Savella® (milnacipran HCl) TabletsInitial U.S. Approval: 2009

Approved
Approval ID

8b720a1e-034b-4583-b80d-105a794cce74

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 6, 2023

Manufacturers
FDA

Cardinal Health 107, LLC

DUNS: 118546603

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

milnacipran hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-4626
Application NumberNDA022256
Product Classification
M
Marketing Category
C73594
G
Generic Name
milnacipran hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2018
FDA Product Classification

INGREDIENTS (10)

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
milnacipran hydrochlorideActive
Quantity: 50 mg in 1 1
Code: RNZ43O5WW5
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Savella - FDA Drug Approval Details