Home Applications 075167 Application 075167
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075167-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04
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 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075167-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-05-04 e64feba35796…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-1029 Wal-Zan Wal-Zan Walgreens Company ANDA Current 0363-1029 Wal-Zan Wal-Zan Walgreens Company ANDA Current 57896-765 ACID REDUCER 75 Ranitidine Hydrochloride GERI-CARE PHARMACEUTICAL CORP ANDA Current 60505-0160 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current 60505-0160 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current 60505-0160 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current 60505-2881 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current 60505-2881 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current 60505-2881 Ranitidine Ranitidine hydrochloride Apotex Corp. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30779 ORIG 2000-05-04