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Alogliptin

These highlights do not include all the information needed to use ALOGLIPTIN TABLETS safely and effectively. See full prescribing information for ALOGLIPTIN TABLETS. Alogliptin Tablets, for oral use Initial U.S. Approval: 2013

Approved
Approval ID

38d30e4f-4212-4f7a-96b5-74b277b56cba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 24, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Alogliptin

PRODUCT DETAILS

NDC Product Code50090-5574
Application NumberNDA022271
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMarch 31, 2022
Generic NameAlogliptin

INGREDIENTS (14)

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ALOGLIPTIN BENZOATEActive
Quantity: 25 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
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Alogliptin - FDA Approval | MedPath