Home Applications 207673 Application 207673
Type ANDA
Sponsor DR REDDYS LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207673-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2018-05-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A207673-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2018-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207673-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2018-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207673-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2018-05-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207673-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2018-05-15 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 7 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-3298 Esomeprazole Magnesium Esomeprazole Magnesium Walgreens Company ANDA Current 0536-1230 Esomeprazole Magnesium Esomeprazole Magnesium RUGBY LABORATORIES ANDA Current 0536-1230 Esomeprazole Magnesium Esomeprazole Magnesium RUGBY LABORATORIES ANDA Current 11822-8862 Esomeprazole Magnesium Esomeprazole Magnesium Rite Aid Corporation ANDA Current 30142-261 Esomeprazole Magnesium Esomeprazole Magnesium The Kroger Co. ANDA Current 30142-261 Esomeprazole Magnesium Esomeprazole Magnesium The Kroger Co. ANDA Current 30142-261 Esomeprazole Magnesium Esomeprazole Magnesium The Kroger Co. ANDA Current 37808-115 Esomeprazole Magnesium Esomeprazole Magnesium HEB ANDA Current 37808-115 Esomeprazole Magnesium Esomeprazole Magnesium HEB ANDA Current 43598-407 Esomeprazole Magnesium Esomeprazole Magnesium Dr. Reddy's Laboratories Inc ANDA Current 43598-407 Esomeprazole Magnesium Esomeprazole Magnesium Dr. Reddy's Laboratories Inc ANDA Current 43598-407 Esomeprazole Magnesium Esomeprazole Magnesium Dr. Reddy's Laboratories Inc ANDA Current 43598-812 Esomeprazole Magnesium Esomeprazole Magnesium Dr. Reddy's Laboratories Inc. ANDA Current 43598-812 Esomeprazole Magnesium Esomeprazole Magnesium Dr. Reddy's Laboratories Inc. ANDA Current 53943-527 Esomeprazole Magnesium Esomeprazole Magnesium Discount Drug Mart, Inc ANDA Current 63868-425 Esomeprazole Magnesium Esomeprazole Magnesium CHAIN DRUG MARKETING ASSOCIATION INC ANDA Current 63868-425 Esomeprazole Magnesium Esomeprazole Magnesium CHAIN DRUG MARKETING ASSOCIATION INC ANDA Current 69618-056 Esomeprazole Esomeprazole Reliable 1 Laboratories ANDA Current 69618-056 Esomeprazole Esomeprazole Reliable 1 Laboratories ANDA Current 69842-277 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy ANDA Current 69842-277 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy ANDA Current 69842-277 Esomeprazole Magnesium Esomeprazole Magnesium CVS Pharmacy ANDA Current 70000-0032 Esomeprazole Magnesium Esomeprazole Magnesium CARDINAL HEALTH ANDA Current 70000-0032 Esomeprazole Magnesium Esomeprazole Magnesium CARDINAL HEALTH ANDA Current 70000-0032 Esomeprazole Magnesium Esomeprazole Magnesium CARDINAL HEALTH ANDA Current 71713-202 Esomeprazole Magnesium Esomeprazole Magnesium Thirty Madison Inc ANDA Current 71713-202 Esomeprazole Magnesium Esomeprazole Magnesium Thirty Madison Inc ANDA Current