Application 020251
- Type
- NDA
- Sponsor
- GLAXO GRP LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 150MG BASE | No | No |
| 002 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | GRANULE, EFFERVESCENT;ORAL | EQ 150MG BASE/PACKET | No | No |
| 003 | ZANTAC 25 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 25MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020251-001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | ||
| N020251-002 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | ||
| N020251-003 | ZANTAC 25 | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 |
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.
| 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 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020251-002 | ZANTAC 150 | EQ 150MG BASE/PACKET | GRANULE, EFFERVESCENT / ORAL | 1994-03-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020251-003 | ZANTAC 25 | EQ 25MG BASE | TABLET, EFFERVESCENT / ORAL | 2004-04-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020251-001 | ZANTAC 150 | EQ 150MG BASE | TABLET, EFFERVESCENT / ORAL | 1994-03-31 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ranitidine Hydrochloride | RANITIDINE HYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 7bf94bf7-fa11-70be-9f65-fe26a3db5a63 | 2018-11-21 | Adverse reactions | RANITIDINE HYDROCHLORIDE |
| Acid Reducer | RANITIDINE HYDROCHLORIDE | WinCo Foods, LLC | 70bc7062-ab3c-43eb-b524-0d8c6d1a674d | 2014-12-10 | Warnings | RANITIDINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24662 | SUPPL | 2009-11-12 |
| 12375 | SUPPL | 2009-10-06 |
| 34434 | SUPPL | 2009-03-27 |
| 2249 | SUPPL | 2009-02-19 |
| 2248 | SUPPL | 2006-07-21 |
| 34433 | SUPPL | 2005-05-02 |
| 2247 | SUPPL | 2005-05-02 |
| 24660 | SUPPL | 2004-07-01 |
| 34432 | SUPPL | 2004-05-03 |
| 2246 | SUPPL | 2004-04-07 |
| 20557 | SUPPL | 2003-04-29 |
| 24661 | SUPPL | 2002-01-07 |