DURLAZA
These highlights do not include all the information needed to use DURLAZA safely and effectively. See full prescribing information for DURLAZA. DURLAZA (aspirin) Extended Release Capsules, for oral useInitial U.S. Approval:2015
Approved
Approval ID
4c2a1403-3862-1efd-0a91-444989222b37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2015
Manufacturers
FDA
New Haven Pharmaceuticals, Inc.
DUNS: 078715268
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetylsalicylic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58487-001
Application NumberNDA200671
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acetylsalicylic Acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2015
FDA Product Classification
INGREDIENTS (10)
EthylcellulosesInactive
Code: 7Z8S9VYZ4B
Classification: IACT
PovidonesInactive
Code: FZ989GH94E
Classification: IACT
AspirinActive
Quantity: 162.5 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
Castor OilInactive
Code: D5340Y2I9G
Classification: IACT
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT