Application 018101
- Type
- NDA
- Sponsor
- ENDO PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYMMETREL | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018101-001 | SYMMETREL | AMANTADINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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UTC | 2026-02 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018101-001 | SYMMETREL | 100MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018101-001 | SYMMETREL | 100MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | AvKARE | 547904f3-84a3-1ccb-e063-6294a90a6fb6 | 2026-06-17 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | A-S Medication Solutions | da693bb0-0cc8-485d-89a7-c8cf28d440f3 | 2026-05-15 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | 6326d7f5-4c7c-4541-8db1-c582f1525f60 | 2026-04-15 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | Cardinal Health 107, LLC | 5989098d-2855-4b5f-9a06-64a83656c078 | 2026-04-08 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | Zhejiang Jutai Pharmaceutical Co., Ltd. | 9c5e0c61-372b-4d1b-8882-e13f6af8fed0 | 2026-03-26 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Strides Pharma Inc. | e4d8f36f-d668-4728-8dca-b1c22bd9aedb | 2026-01-30 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Major Pharmaceuticals | b2f7da34-ad78-4db3-9af1-bdd341e09f16 | 2026-01-05 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | 3c448cb3-7996-4a83-a9ad-23a00a431fbe | 2025-12-19 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Strides Pharma Inc. | 9a99bb98-82a4-4b9e-9216-554dade72a3c | 2025-12-12 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Chartwell RX, LLC | 52aa093c-82cc-4d81-b072-86a2b8adc9c5 | 2025-12-12 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 63d9d4aa-5f92-45b0-98d0-d6ec38b727cb | 2025-12-11 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | 56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f | 2025-10-24 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | 96aefbca-fe71-42ef-8079-d0d9e7370ccb | 2025-10-22 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | a10bf8b5-bf70-4090-b4b2-a0be252b9fe4 | 2025-10-22 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Marlex Pharmaceuticals Inc | 25af52ee-9b29-4c07-a383-62d4537b63e0 | 2025-09-10 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3dd7f2a6-5a91-81a2-e063-6294a90a33db | 2025-09-02 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | be411327-5ac7-46df-b5e4-32a11b419b15 | 2025-08-07 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | 8e578f11-6112-4a1f-8de4-a76870bb62c7 | 2025-07-14 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Advagen Pharma Limited | c3b9e7f0-be6d-4f37-9277-54bb0ba8b158 | 2025-07-09 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 5232b933-1df9-43b4-8ac2-61bfa4855e68 | 2025-07-09 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |