Application 077355
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | TABLET, CHEWABLE;ORAL | 800MG;10MG;165MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 |
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 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| DUAL ACTION COMPLETE | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Amazon.com Services LLC | 4e8a936c-b876-4923-ad9e-d23537b5d7cf | 2026-07-28 | Warnings | 077355 ANDA077355 |
| COMPLETE ACID REDUCER | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 962ced24-0fb3-4aba-b32e-2e6fa1c1c5d7 | 2026-07-22 | Warnings | 077355 ANDA077355 |
| Good Neighbor Pharmacy Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Amerisource Bergen | b7453c0e-b452-409b-a324-83fdd105bfd0 | 2026-06-02 | Warnings | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Meijer Distribution Inc | 50fe57e1-6678-4697-9b35-4673db67d4fb | 2026-06-01 | Warnings | 077355 ANDA077355 |
| COMPLETE ACID REDUCER | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 6ccc03bd-3f36-452a-8945-b3d71cce8241 | 2026-04-08 | Warnings | 077355 ANDA077355 |
| Acid Reducer Plus Antacid | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Rite Aid Corporation | 5490abe2-11f0-45a8-aefa-f70263ff1da8 | 2026-03-27 | Warnings | 077355 ANDA077355 |
| GOOD SENSE DUAL ACTION COMPLETE | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | L. Perrigo Company | b5a36da3-7316-493c-b50f-fc5393d858c0 | 2026-03-24 | Warnings | 077355 ANDA077355 |
| ACID REDUCER COMPLETE | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Walgreen Company | b94b16d3-b52f-4d70-bbb0-d9fb074c891c | 2026-03-19 | Warnings | 077355 ANDA077355 |
| complete dual action | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | HyVee Inc | 237efe92-b302-4e11-93fe-7b0f727a00aa | 2026-03-12 | Warnings | 077355 ANDA077355 |
| Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Walgreen Company | 6f1dcfda-c12a-4c3b-80a2-c9e15517c88f | 2026-03-03 | Warnings | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Meijer Distribution Inc | 6e8ed233-9ffb-46f7-9632-d5bc3d3a558b | 2026-01-20 | Warnings | 077355 ANDA077355 |
| equaline complete dual action | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | United Natural Foods, Inc. dba UNFI | c32cb5be-e1f8-4510-8685-5e03a7d4224c | 2026-01-13 | Warnings | 077355 ANDA077355 |
| Good Sense Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | L. Perrigo Company | b7154648-8c8c-4ce6-88b7-5442a16143c5 | 2025-11-14 | Warnings | 077355 ANDA077355 |
| acid reducer complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Safeway | 4f0a178c-d0ed-4bbc-a8ce-fda3789d25f0 | 2025-10-14 | Warnings | 077355 ANDA077355 |
| Up and Up Dual Action Acid Reducer and Antacid | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Target Corporation | 2f020677-77a0-4e13-9397-e9deeda63293 | 2025-09-10 | Warnings | 077355 ANDA077355 |
| topcare dual action complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Topco Associates LLC | 2c5a1694-d6e9-4679-b421-61eaad5403a4 | 2025-09-04 | Warnings | 077355 ANDA077355 |
| CareOne Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | American Sales Company | 5d4bea42-25d5-4943-b5ed-471eccd36bf8 | 2025-08-29 | Warnings | 077355 ANDA077355 |
| CareOne Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | American Sales Company | 19045840-2d25-43af-8c92-f36c8b903b28 | 2025-08-28 | Warnings | 077355 ANDA077355 |
| ACID REDUCER COMPLETE | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Safeway | 484ad323-82cf-4157-bacb-236af8210c87 | 2025-08-27 | Warnings | 077355 ANDA077355 |
| dual action complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Publix Super Markets Inc | 913073fe-22ce-40a3-ad22-bf3027c21e99 | 2025-08-14 | Warnings | 077355 ANDA077355 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62011-0276 | health mart dual action complete | famotidine, calcium carbonate and magnesium hydroxide | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0276 | health mart dual action complete | famotidine, calcium carbonate and magnesium hydroxide | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0276 | health mart dual action complete | famotidine, calcium carbonate and magnesium hydroxide | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0276 | health mart dual action complete | famotidine, calcium carbonate and magnesium hydroxide | Strategic Sourcing Services LLC | ANDA | Current |
| 69256-004 | HARRIS TEETER ACID REDUCER COMPLETE | famotidine, calcium carbonate and magnesium hydroxide | Harris Teeter, LLC | ANDA | Current |
| 69256-004 | HARRIS TEETER ACID REDUCER COMPLETE | famotidine, calcium carbonate and magnesium hydroxide | Harris Teeter, LLC | ANDA | Current |
| 69256-004 | HARRIS TEETER ACID REDUCER COMPLETE | famotidine, calcium carbonate and magnesium hydroxide | Harris Teeter, LLC | ANDA | Current |
| 70000-0416 | leader acid reducer complete | Famotidine, Calcium Carbonate, Magnesium Hydroxide | Cardinal Health | ANDA | Current |
| 70000-0416 | leader acid reducer complete | Famotidine, Calcium Carbonate, Magnesium Hydroxide | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0416 | leader acid reducer complete | Famotidine, Calcium Carbonate, Magnesium Hydroxide | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0416 | leader acid reducer complete | Famotidine, Calcium Carbonate, Magnesium Hydroxide | Cardinal Health | ANDA | Current |
| 70000-0416 | leader acid reducer complete | Famotidine, Calcium Carbonate, Magnesium Hydroxide | Cardinal Health | ANDA | Current |
| 70000-0582 | leader acid reducer complete | famotidine, calcium carbonate and magnesium hydroxide | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0582 | leader acid reducer complete | famotidine, calcium carbonate and magnesium hydroxide | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 72288-321 | Basic Care Dual Action Complete | famotidine, calcium carbonate and magnesium hydroxide | Amazon.com Services Inc. | ANDA | Current |
| 72288-321 | Basic Care Dual Action Complete | famotidine, calcium carbonate and magnesium hydroxide | Amazon.com Services LLC | ANDA | Current |
| 72288-321 | Basic Care Dual Action Complete | famotidine, calcium carbonate and magnesium hydroxide | Amazon.com Services LLC | ANDA | Current |
| 72288-321 | Basic Care Dual Action Complete | famotidine, calcium carbonate and magnesium hydroxide | Amazon.com Services LLC | ANDA | Current |
| 72288-321 | Basic Care Dual Action Complete | famotidine, calcium carbonate and magnesium hydroxide | Amazon.com Services LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31227 | ORIG | 2008-03-20 |