Aurolife Pharma LLC
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 2400 Route 130 North, Dayton, New Jersey (NJ) 08810, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3005796917 · DUNS 829084461
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2021-12-07
- VAIDrug Quality Assurance2019-10-22
- VAIDrug Quality Assurance2018-06-14
- NAIDrug Quality Assurance2016-07-28
- NAIDrug Quality Assurance2016-01-12
- NAIDrug Quality Assurance2015-07-09
- VAIDrug Quality Assurance2013-10-15
- VAIDrug Quality Assurance2011-11-02
- VAIDrug Quality Assurance2011-05-25
- NAIDrug Quality Assurance2009-05-11
Drugs this plant is listed as making
27 distinct drugs across 96 products name this site in their FDA label.
- Acetaminophen and Codeine PhosphateAurolife Pharma, LLC
- Amphetamine SulfateAurolife Pharma, LLC
- AtenololAurobindo Pharma Limited
- Butalbital, Acetaminophen and CaffeineAurolife Pharma, LLC
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfatein shortageAurolife Pharma, LLC
- Dextroamphetamine SulfateAurolife Pharma, LLC
- Donepezil HydrochlorideAurobindo Pharma Limited
- GabapentinAurobindo Pharma Limited
- Hydrocodone Bitartrate and AcetaminophenAurolife Pharma, LLC
- Hydrocodone Bitartrate and IbuprofenAurolife Pharma, LLC
- Hydromorphone Hydrochloridein shortageAurolife Pharma, LLC
- LevofloxacinAurobindo Pharma Limited
- Methadone HydrochlorideAurolife Pharma, LLC
- Methylphenidate Hydrochloridein shortageAurolife Pharma, LLC
- Metoprolol TartrateAurobindo Pharma Limited
- MirtazapineAurolife Pharma LLC
- Montelukast SodiumAurobindo Pharma Limited
- OlanzapineAurobindo Pharma Limited
- Oxycodone and AcetaminophenAurolife Pharma, LLC
- Oxycodone HydrochlorideAurolife Pharma, LLC
- Oxycodone Hydrochloride Oral SolutionAurolife Pharma, LLC
- ParoxetineAurolife Pharma LLC
- Phentermine HydrochlorideAurolife Pharma, LLC
- Rosuvastatin CalciumRising Pharma Holdings, Inc.
- SimvastatinAurobindo Pharma Limited
- Valacyclovir HydrochlorideAurobindo Pharma Limited
- ValsartanAurobindo Pharma Limited
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.