Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202461
Company: DR REDDYS LABS LTD
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
09/04/2018 ORIG-1 Tentative Approval

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 202461 DR REDDYS LABS LTD

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 202461 DR REDDYS LABS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English