Home Applications 207891 Application 207891
Type ANDA
Sponsor SUN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL 20MG 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 A207891-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL 2018-10-12
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 A207891-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL 2018-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207891-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL 2018-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207891-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL 2018-10-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207891-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL 2018-10-12 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 · 14 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30142-992 omeprazole omeprazole THE KROGER COMPANY ANDA Current 30142-992 omeprazole omeprazole THE KROGER COMPANY ANDA Current 37835-001 Omeprazole Omeprazole BI-MART ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 51660-029 Omeprazole Omeprazole OHM LABORATORIES INC. ANDA Current 55681-306 Omeprazole OMEPRAZOLE Twin Med LLC ANDA Current 55681-306 Omeprazole OMEPRAZOLE Twin Med LLC ANDA Current 57483-840 omeprazole omeprazole INNOVUS PHARMACEUTICALS, INC. ANDA Current 62756-377 Omeprazole Omeprazole Sun Pharmaceutical Industries, Inc. ANDA Current 62756-377 Omeprazole Omeprazole Sun Pharmaceutical Industries, Inc. ANDA Current 62756-377 Omeprazole Omeprazole Sun Pharmaceutical Industries, Inc. ANDA Current 70677-0148 Omeprazole Omeprazole Strategic Sourcing Services ANDA Current 72036-981 Omeprazole OMEPRAZOLE HARRIS TEETER ANDA Current 72036-981 Omeprazole OMEPRAZOLE HARRIS TEETER ANDA Current 72559-014 omeprazole omeprazole Little Pharma, Inc. ANDA Current 72559-014 omeprazole omeprazole Little Pharma, Inc. ANDA Current 72559-014 omeprazole omeprazole Little Pharma, Inc. ANDA Current 72559-014 omeprazole omeprazole Little Pharma, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 56473 ORIG 2018-11-15