Application 215766
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 10MG | No | No |
| 002 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215766-001 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | ||
| A215766-002 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 |
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 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215766-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-08 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215766-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-08 | 6a51e52b5d6a… |
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 |
|---|---|---|---|---|---|---|
| Goodmeds Famotidine 20mg 500 count | FAMOTIDINE 20MG | Cabinet Health P.B.C. | 5592d0f0-03fd-c914-e063-6294a90a2826 | 2026-07-01 | Warnings | 215766 ANDA215766 |
| Heartburn Relief | FAMOTIDINE | Shield Pharmaceuticals Corp | a12ec91d-244f-45c5-8590-d1e4485fe361 | 2025-10-31 | Warnings | 215766 ANDA215766 |
| Famotidine | FAMOTIDINE | Little Pharma, Inc. | 33dc93a5-ee03-2e68-e063-6294a90aeee1 | 2025-07-05 | Warnings | 215766 ANDA215766 |
| famotidine | FAMOTIDINE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6 | 2024-03-27 | Warnings | 215766 ANDA215766 |
| famotidine | FAMOTIDINE | Camber Consumer Care Inc | ebe3ca30-df25-4c56-8935-414a3431b5b9 | 2022-10-11 | Warnings | 215766 ANDA215766 69230-326 69230-327 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69230-326 | famotidine | famotidine | Camber Consumer Care Inc | ANDA | Current |
| 69230-326 | famotidine | famotidine | Camber Consumer Care Inc | ANDA | Current |
| 69230-327 | famotidine | famotidine | Camber Consumer Care Inc | ANDA | Current |
| 69230-327 | famotidine | famotidine | Camber Consumer Care Inc | ANDA | Current |