Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074190
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/30/1994 | 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 |
|---|---|---|---|---|---|
| 02/15/2025 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2021 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/25/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/14/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/28/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NAPROXEN
SUSPENSION;ORAL; 25MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NAPROSYN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 018965 | ATNAHS PHARMA US |
| NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 212705 | AMNEAL |
| NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 215776 | HETERO LABS LTD III |
| NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 074190 | HIKMA |
| NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 211910 | NOVITIUM PHARMA |