Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208871
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/28/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208871Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/12/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/12/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION; 0.4MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NALOXONE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070299 | HIKMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216624 | ACCORD HLTHCARE |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214785 | BAXTER HLTHCARE CORP |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214792 | BAXTER HLTHCARE CORP |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212456 | EUGIA PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213573 | FRESENIUS KABI USA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212300 | HIKMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070172 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070256 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070257 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218404 | MANKIND PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204997 | MYLAN INSTITUTIONAL |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205014 | MYLAN INSTITUTIONAL |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208871 | RISING PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208872 | RISING PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207633 | SOMERSET THERAPS LLC |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207634 | SOMERSET THERAPS LLC |