KENVUE BRANDS LLC
Overview
KENVUE BRANDS LLC is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering NASAL NICOTINE SOLUTION (NNS); NICORETTE; NICOTINE OROMUCOSAL SPRAY; NICOTINE POLACRILEX LOZENGE.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances KENVUE BRANDS LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
KENVUE BRANDS LLC holds 4 active (4 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- NICOTINE POLACRILEX LOZENGEActive2018-02-09
- NICOTINE OROMUCOSAL SPRAYActive2015-07-06
- NASAL NICOTINE SOLUTION (NNS)Active1989-07-10
- NICORETTEActive1980-06-10
FDA compliance signals
6 FDA enforcement records linked to this company.
- 4832026-02-10
SOPs not followed / documented
- 4832026-02-10
Buildings not maintained in good state of repair
- recall — Class II2025-11-05
Defective Container
- 4832017-07-07
Failing drug products not rejected
- 4832015-05-06
Incoming lots - conformance to written specs-
- warning_letter2010-09-27
FDA Warning Letter (drug product)
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