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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211951
Company: PADAGIS ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211951Orig1s000TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2023 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211951Orig1s003ltr.pdf

NALOXONE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 4MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 211951 PADAGIS ISRAEL
NARCAN NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 208411 EMERGENT
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