Application 075511
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A075511-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | |
| A075511-002 | FAMOTIDINE | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075511-001 | AB |
| A075511-002 | 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 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075511-001 | FAMOTIDINE | 20MG | TABLET / ORAL | AB | 2001-04-16 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075511-002 | FAMOTIDINE | 40MG | TABLET / ORAL | AB | 2001-04-16 | 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 | A075511-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075511-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075511-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075511-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075511-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075511-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075511-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075511-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075511-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075511-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075511-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075511-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075511-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075511-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075511-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075511-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075511-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075511-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075511-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075511-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075511-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075511-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075511-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075511-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075511-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075511-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075511-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075511-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075511-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075511-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075511-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075511-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075511-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075511-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075511-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075511-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075511-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075511-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075511-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075511-002 | 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 | Proficient Rx LP | d60bde93-f512-4071-9e4b-1d8318def3bc | 2026-03-01 | Warnings, Adverse reactions | 075511 ANDA075511 71205-276 |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | f2b6da72-72ea-d81b-e053-2995a90a9526 | 2026-01-01 | Warnings, Adverse reactions | 075511 ANDA075511 |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | 03503cd5-bd8e-4bff-b90d-1a71c5225b91 | 2025-12-26 | Warnings, Adverse reactions | 075511 ANDA075511 51655-102 |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 5798d282-ce83-49aa-bc33-13203f2b5285 | 2025-10-15 | Warnings, Adverse reactions | 075511 ANDA075511 43063-533 |
| Famotidine | FAMOTIDINE | A-S Medication Solutions | 2bde8e1d-078f-4ba1-9ccb-29de6e36d8c4 | 2023-12-18 | Warnings, Adverse reactions | 075511 ANDA075511 |
| Famotidine | FAMOTIDINE | A-S Medication Solutions | 74ff64f2-d882-411f-bac8-29dfa4cb4f10 | 2023-08-09 | Warnings, Adverse reactions | 075511 ANDA075511 50090-1044 |
| Famotidine | FAMOTIDINE | Proficient Rx LP | fe21daca-ac48-4b46-9cb3-9a69af0c6a84 | 2023-03-01 | Warnings, Adverse reactions | 075511 ANDA075511 |
| Famotidine | FAMOTIDINE | Teva Pharmaceuticals USA, Inc. | 4c6f4f9e-f3f5-4ecf-9f40-887e037e8847 | 2019-01-01 | Warnings, Adverse reactions | 075511 ANDA075511 0172-5728 0172-5729 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0172-5728 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5728 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5728 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5728 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5729 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5729 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5729 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5729 | Famotidine | Famotidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-4582 | Famotidine | Famotidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4582 | Famotidine | Famotidine | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-4582 | Famotidine | Famotidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4594 | Famotidine | Famotidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8301 | Famotidine | Famotidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8301 | Famotidine | Famotidine | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 12634-967 | Famotidine | Famotidine | Apotheca Inc. | ANDA | Current |
| 43063-086 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-086 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-086 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-086 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-086 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-533 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-533 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-533 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-533 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-533 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-881 | Famotidine | Famotidine | medsource pharmaceuticals | ANDA | Current |
| 45865-881 | Famotidine | Famotidine | medsource pharmaceuticals | ANDA | Current |
| 50090-1044 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-3305 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-3305 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-4389 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50436-0999 | Famotidine | Famotidine | Unit Dose Services | ANDA | Current |
| 51655-102 | Famotidine | Famotidine | Northwind Pharmaceuticals,LLC | ANDA | Current |
| 51655-108 | FAMOTIDINE | FAMOTIDINE | Northwind Pharmaceuticals | ANDA | Current |
| 55154-7552 | Famotidine | Famotidine | Cardinal Health | ANDA | Current |
| 55289-765 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-765 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-765 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-765 | Famotidine | Famotidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 63629-7321 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 67046-172 | Famotidine | Famotidine | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1121 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1121 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1121 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1121 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 68071-3181 | Famotidine | Famotidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3181 | Famotidine | Famotidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3181 | Famotidine | Famotidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68645-140 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-140 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-140 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-140 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-140 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-141 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-141 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-6399 | Famotidine | Famotidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6399 | Famotidine | Famotidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6399 | Famotidine | Famotidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0163 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0460 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0460 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0460 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0460 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1415 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1415 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1415 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1415 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1877 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1877 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70934-780 | Famotidine | Famotidine | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-819 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-819 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-276 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30919 | ORIG | 2001-04-16 |