U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204206
Company: DR REDDYS
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
02/18/2020 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204206Orig1s000ltr.pdf

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 204470 ACTAVIS LABS FL INC
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 204920 MYLAN
VIMOVO ESOMEPRAZOLE MAGNESIUM; NAPROXEN EQ 20MG BASE;375MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 022511 HORIZON

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 204470 ACTAVIS LABS FL INC
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 204920 MYLAN
VIMOVO ESOMEPRAZOLE MAGNESIUM; NAPROXEN EQ 20MG BASE;500MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 022511 HORIZON
Back to Top