FDA.reportPublic FDA data

Application 211951

Type
ANDA
Sponsor
PADDOCK LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDESPRAY, METERED;NASAL4MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-811NALOXONE HYDROCHLORIDEnaloxone hydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
63629-9321NALOXONE HYDROCHLORIDEnaloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-9321NALOXONE HYDROCHLORIDEnaloxone hydrochlorideBryant Ranch PrepackANDACurrent
71205-707NALOXONE HYDROCHLORIDEnaloxone hydrochlorideProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74882SUPPL 2023-07-25
65861ORIG2021-01-07