Home Applications 075208 Application 075208
Type ANDA
Sponsor WOCKHARDT LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE No No 002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075208-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 A075208-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1998-12-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1998-12-17 74a2ff9319b5…
Observed Orange Book normalized TE history# 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.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55648-906 RANITIDINE RANITIDINE WOCKHARDT LIMITED ANDA Current 55648-907 RANITIDINE RANITIDINE WOCKHARDT LIMITED ANDA Current 64679-906 RANITIDINE ranitidine Wockhardt USA LLC. ANDA Current 64679-906 RANITIDINE ranitidine Wockhardt USA LLC. ANDA Current 64679-907 RANITIDINE ranitidine Wockhardt USA LLC. ANDA Current 64679-907 RANITIDINE ranitidine Wockhardt USA LLC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8564 ORIG 1998-12-17