Application 217400
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 20MG | No | No |
| 002 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217400-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | |
| A217400-002 | FAMOTIDINE | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217400-001 | AB |
| A217400-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | 79d66fd596c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217400-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2024-08-06 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217400-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2024-08-06 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217400-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217400-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217400-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217400-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217400-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217400-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217400-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217400-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217400-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217400-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217400-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217400-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217400-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217400-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217400-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217400-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217400-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217400-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217400-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217400-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217400-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217400-002 | AB | 1 | 79d66fd596c7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217400-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217400-002 | AB | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Famotidine | FAMOTIDINE | Advanced Rx of Tennessee, LLC | 5648ca13-1add-56ec-e063-6294a90a6f29 | 2026-07-10 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | REMEDYREPACK INC. | 8dbf43e0-856f-443b-b8a4-c69e006878ea | 2026-04-24 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | Redpharm Drug | 44f3f63d-4522-91e4-e063-6394a90a6d1b | 2025-12-02 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | Novadoz Pharmaceuticals LLC | 74a24590-a0b6-4607-8e67-9fadce53389b | 2025-11-12 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | c133a9e1-ca48-4ee2-8768-01f44f5dd511 | 2025-10-14 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | Preferred Pharmaceuticals Inc. | 6edbd842-cf86-48a5-bc22-967620a2b5cb | 2025-09-05 | Warnings, Adverse reactions | 217400 ANDA217400 |
| Famotidine | FAMOTIDINE | REMEDYREPACK INC. | 669fbd46-cae5-4477-884e-8eca893d2e05 | 2025-07-18 | Warnings, Adverse reactions | 217400 ANDA217400 |