Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072076
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/24/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/16/2023 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/16/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/04/2008 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/14/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216624 | ACCORD HLTHCARE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216977 | BPI LABS |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213209 | DR REDDYS |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213279 | EUGIA PHARMA |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213573 | FRESENIUS KABI USA |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212300 | HIKMA |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072076 | INTL MEDICATION |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213843 | MYLAN LABS LTD |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215964 | PAR STERILE PRODUCTS |