Application 090402
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TACROLIMUS | TACROLIMUS | CAPSULE;ORAL | EQ 5MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090402-001 | TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 |
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 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090402-001 | TACROLIMUS | EQ 5MG BASE | CAPSULE / ORAL | 2010-07-01 | 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 |
|---|---|---|---|---|---|---|
| Tacrolimus | TACROLIMUS | Stellon Biotech Inc. | 6b89e8a4-9f11-42e3-8e79-fe617e7c461f | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Major Pharmaceuticals | 213f6047-f897-48a7-b78a-45d7124f2f16 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| tacrolimus | TACROLIMUS | A-S Medication Solutions | 3519febc-c9df-4559-b07a-92f8b0c7e770 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | tacrolimus TACROLIMUS |
| tacrolimus | TACROLIMUS | NORTHSTAR RX LLC | 875f4962-557e-4e12-ad7b-cb5fb6f2a65f | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Major Pharmaceuticals | 0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Glenmark Pharmaceuticals Inc., USA | c2d2e3a1-f346-4245-b445-6dd44e371180 | 2026-04-15 | Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Safecor Health LLC | 393cd10e-133c-4d6b-b024-270eb82edbb3 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Jubilant Cadista Pharmaceuticals Inc. | 651bd506-96b0-43e5-a4dd-db03bf9154c9 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 1bf44a84-14fd-4f80-ad8a-99b1431d631f | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| tacrolimus | TACROLIMUS | Glenmark Pharmaceuticals Inc., USA | 4b310c6b-e035-4e44-9573-4001d58b2ad5 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | BPI Labs LLC | 3e8bc65e-8048-4073-8e45-570330603000 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Ajenat Pharmaceuticals LLC | ca08d4aa-3de2-4a9d-9554-6288e5d36f29 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Ascend Laboratories, LLC | 55467f4b-8437-43a3-b6d9-1bc2a13b4c11 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Golden State Medical Supply, Inc. | 34ec4989-6933-4237-ae1e-50a0cb90a2fe | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Cardinal Health 107, LLC | e898ee90-faae-42a8-b652-be1c8730d856 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Nexus Pharmaceuticals, LLC | 9d502961-e9c0-4611-92bf-ce742a7b962c | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Amneal Pharmaceuticals NY LLC | 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS OINTMENT 0.1% | Encube Ethicals, Inc. | 43b38551-6c5e-48a4-a453-9286f1c16b34 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | Tacrolimus |
| Tacrolimus | TACROLIMUS | Sandoz Inc. | 46ac55cf-d85e-4c34-bb33-f49e078c4a03 | 2025-08-30 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |
| Tacrolimus | TACROLIMUS | Bryant Ranch Prepack | a2e55495-10cc-4f6e-b866-1e7d6e45888b | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Tacrolimus TACROLIMUS |