Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209522
Company: TEVA PHARMS USA
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-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
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 | 209522 | TEVA PHARMS USA |