Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211910
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN | NAPROXEN | 25MG/ML | SUSPENSION;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/10/2021 | ORIG-1 | Approval | STANDARD |
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 |