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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209522
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Prescription AB 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
04/19/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209522Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2021 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/05/2021 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

NALOXONE HYDROCHLORIDE

SPRAY, METERED;NASAL; 4MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 211951 PADAGIS ISRAEL
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 209522 TEVA PHARMS USA
NARCAN NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 208411 EMERGENT
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