Application 078916
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
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 |
|---|---|---|---|---|---|---|---|
| A078916-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | |
| A078916-002 | FAMOTIDINE | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078916-001 | AB |
| A078916-002 | 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 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078916-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2009-05-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078916-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2009-05-22 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078916-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078916-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078916-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078916-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078916-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078916-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078916-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078916-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078916-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078916-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078916-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078916-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078916-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078916-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078916-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078916-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078916-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078916-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078916-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078916-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078916-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078916-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078916-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078916-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078916-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078916-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078916-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078916-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078916-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078916-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078916-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078916-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078916-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078916-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078916-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078916-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078916-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078916-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078916-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078916-002 | AB | 1 | 782e0a99824c… |
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 | Preferred Pharmaceuticals Inc. | 32fd4101-15cb-411e-8b9d-270ec0592c6e | 2026-06-08 | Warnings, Adverse reactions | 078916 ANDA078916 |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | cf2cd30e-9a0f-4b63-975c-5b551691cda9 | 2026-05-21 | Warnings, Adverse reactions | 078916 ANDA078916 71335-0409 |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | db3af7cc-efc6-4934-acff-8bb2d31fe829 | 2026-05-19 | Warnings, Adverse reactions | 078916 ANDA078916 71335-0231 |
| Famotidine | FAMOTIDINE | Alembic Pharmaceuticals Inc. | f149ecc1-d66c-42f9-a3f4-2ab6a522942b | 2026-01-09 | Warnings, Adverse reactions | 078916 ANDA078916 62332-001 62332-002 |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | 43454e0f-4e1e-bbc6-e063-6394a90a5ac4 | 2025-12-29 | Warnings, Adverse reactions | 078916 ANDA078916 |
| Famotidine | FAMOTIDINE | NCS HealthCare of KY, LLC dba Vangard Labs | 59b17677-d805-4d9e-9c64-96385ae47bff | 2025-01-27 | Warnings, Adverse reactions | 078916 ANDA078916 |
| FAMOTIDINE | FAMOTIDINE | direct rx | b1b82d2a-cdb5-3e22-e053-2995a90a917d | 2025-01-17 | Warnings, Adverse reactions | 078916 ANDA078916 72189-141 |
| Famotidine | FAMOTIDINE | Alembic Pharmaceuticals Limited | 7c0f3fa5-0a44-4a98-bc43-8bff8e95c462 | 2024-10-31 | Adverse reactions | 078916 ANDA078916 46708-294 46708-293 |
| Famotidine | FAMOTIDINE | NuCare Pharmaceuticals, Inc. | 4b820924-24ad-4a2f-e054-00144ff88e88 | 2024-07-19 | Adverse reactions | 078916 ANDA078916 68071-3201 |
| Famotidine | FAMOTIDINE | Proficient Rx LP | 9baf2596-b771-4bae-a03c-d3af6716821d | 2022-05-02 | Adverse reactions | 078916 ANDA078916 63187-723 |
| Famotidine | FAMOTIDINE | Aphena Pharma Solutions - Tennessee, LLC | b1839d23-20f4-4651-a7d2-8bc3a7583917 | 2020-07-06 | Warnings, Adverse reactions | 078916 ANDA078916 71610-399 |
| Famotidine | FAMOTIDINE | Proficient Rx LP | 92048836-e692-4ce1-93f4-88b00acabcde | 2019-11-01 | Adverse reactions | 078916 ANDA078916 63187-908 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46708-293 | Famotidine | Famotidine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-293 | Famotidine | Famotidine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-294 | Famotidine | Famotidine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-294 | Famotidine | Famotidine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50436-1000 | Famotidine | Famotidine | Unit Dose Services | ANDA | Current |
| 53002-1199 | Famotidine | Famotidine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1199 | Famotidine | Famotidine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 60760-070 | Famotidine | Famotidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-070 | Famotidine | Famotidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | DIRECT RX | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | Direct_Rx | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | Direct_Rx | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | DIRECT RX | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | Direct_Rx | ANDA | Current |
| 61919-236 | FAMOTIDINE | FAMOTIDINE | Direct_Rx | ANDA | Current |
| 62332-001 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-001 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-001 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-001 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-001 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-002 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-002 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-002 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-002 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-002 | Famotidine | Famotidine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63187-723 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63187-723 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63187-723 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63187-723 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63187-908 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63187-908 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 63629-7926 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7926 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7926 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 66267-543 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-543 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-648 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-648 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-412 | Famotidine | Famotidine | Coupler Enterprises | ANDA | Current |
| 67296-1383 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1383 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1383 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 68001-240 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-240 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-241 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-241 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68071-3201 | Famotidine | Famotidine | NuCare Pharmaceuticals, I | ANDA | Current |
| 68071-3201 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3201 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3305 | Famotidine | Famotidine | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3305 | Famotidine | Famotidine | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3305 | Famotidine | Famotidine | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68788-6859 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6859 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6859 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6859 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6859 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7191 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7191 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7191 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7191 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7191 | Famotidine | Famotidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2469 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70934-540 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-540 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-540 | Famotidine | Famotidine | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-553 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-553 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0231 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0231 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0409 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0409 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0409 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71610-399 | Famotidine | Famotidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-399 | Famotidine | Famotidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-141 | FAMOTIDINE | FAMOTIDINE | direct rx | ANDA | Current |
| 72189-141 | FAMOTIDINE | FAMOTIDINE | direct rx | ANDA | Current |