Application 080140
- Type
- ANDA
- Sponsor
- LANNETT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LANIAZID | ISONIAZID | TABLET;ORAL | 50MG | No | No |
| 002 | LANIAZID | ISONIAZID | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080140-001 | LANIAZID | ISONIAZID | 50MG | TABLET / ORAL | Approved before 1982 | ||
| A080140-002 | LANIAZID | ISONIAZID | 100MG | TABLET / ORAL | Approved before 1982 |
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 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080140-001 | LANIAZID | 50MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080140-002 | LANIAZID | 100MG | TABLET / ORAL | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| isoniazid | ISONIAZID | REMEDYREPACK INC. | 93252cc8-c8d4-401b-bde5-ca8a3b57651e | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Bryant Ranch Prepack | 03bf3bd5-64f9-4491-89fd-96c5c10d0129 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | REMEDYREPACK INC. | 6dab7b7b-a3a9-47ef-b423-134bc6970d8b | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Chartwell RX, LLC | 8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | Coupler LLC | 44592c5c-d11c-148d-e063-6294a90ab35c | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Bryant Ranch Prepack | b6d6dccc-2577-4bbb-896e-5f75b65ee6ca | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | A-S Medication Solutions | ed780e28-a2c3-44dc-898a-d2cbe05eeedf | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | Marlex Pharmaceuticals, Inc. | 312cd403-b211-64ef-e063-6394a90aab88 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Bryant Ranch Prepack | 9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | OMNIVIUM PHARMACEUTICALS LLC. | 35400f1d-fd25-4bfa-a382-ac390e21bf2e | 2025-07-08 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Coupler LLC | 38f4c4af-81da-9b0c-e063-6294a90a8b9d | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Genus Lifesciences | f0b46d1d-2300-457d-a7bd-a88a3f8d2235 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | A-S Medication Solutions | d5039796-6ba0-4fa8-84f7-e47c63d45163 | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Sandoz Inc | 77795c31-1cdf-4a20-b4a1-cd15f5b310f1 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Chartwell RX, LLC | 2e09b1a5-9786-427f-bf00-be15b06eb7e7 | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | Bryant Ranch Prepack | eeaf09a3-5631-4089-9f17-15750c002e32 | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| isoniazid | ISONIAZID | Bryant Ranch Prepack | 63bf1fe0-5d74-4123-88b7-a95d521befca | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | Mylan Institutional Inc. | 60a6b514-fa7f-4bc7-85b0-e5a14fa56b59 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | CMP Pharma, Inc. | db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2 | 2024-11-07 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |
| Isoniazid | ISONIAZID | A-S Medication Solutions | 8a309582-1bb7-4b21-af43-c38710ac83d5 | 2023-06-02 | Boxed warning, Warnings, Adverse reactions | ISONIAZID |