Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217738
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
10/11/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE;375MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213699 | AJANTA PHARMA LTD |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204206 | DR REDDYS |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217738 | SCIEGEN PHARMS INC |
TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE;500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213699 | AJANTA PHARMA LTD |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204206 | DR REDDYS |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217738 | SCIEGEN PHARMS INC |