Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212199
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | No | No |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
10/30/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NAPROXEN SODIUM
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078432 | AMNEAL PHARMS NY |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 200629 | AUROBINDO PHARMA LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078486 | DR REDDYS LABS LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078314 | GLENMARK PHARMS LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 212199 | SCIEGEN PHARMS INC |
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANAPROX DS | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | Yes | AB | 018164 | ATNAHS PHARMA US |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 078432 | AMNEAL PHARMS NY |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 200629 | AUROBINDO PHARMA LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 078486 | DR REDDYS LABS LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 078314 | GLENMARK PHARMS LTD |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 212199 | SCIEGEN PHARMS INC |