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| AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| SYMMETREL | AMANTADINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 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UTC | 2026-02 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||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ZIP | 2025-12 | N018101-001 | SYMMETREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||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… |
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 | BAJAJ MEDICAL, LLC | 38fccce5-1f1e-9350-e063-6394a90a045a | 2025-07-02 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | e3eb34af-6e25-4a3d-a7d2-e9a789e335cc | 2025-06-26 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine HCl | AMANTADINE HYDROCHLORIDE | AvPAK | 461e6444-189e-62ed-6c61-1c36a04459c6 | 2025-06-24 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine HCl | AMANTADINE HYDROCHLORIDE | AvKARE | bfd129ae-8b0a-f118-b7d0-45d106290b63 | 2025-06-24 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine HCl | AMANTADINE HYDROCHLORIDE | Bionpharma Inc. | d6ca4d20-72c5-496c-9ac7-1f5cb407a742 | 2025-06-09 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | EPIC PHARMA LLC | 0f70c79a-92a4-4a38-bbdd-900adc4c2e93 | 2025-06-06 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1b9498b7-125e-4314-baca-b62af6e5511c | 2025-06-06 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 6fd54e00-a714-4442-af95-2515ab3b2ac3 | 2025-06-04 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 609dc911-1e9d-4ebd-b64b-f44054e5582e | 2025-06-04 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | Zydus Lifesciences Limited | 579e6c23-6286-4b80-88de-c86c0e5cc2b2 | 2025-06-04 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP. | 6311b46b-23cc-40c1-93c2-f7c92606386f | 2025-05-12 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Coupler LLC | 2d94073b-c064-c280-e063-6294a90af145 | 2025-02-07 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Proficient Rx LP | a3810649-1301-4332-85df-722b36867b1b | 2025-02-01 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | Coupler LLC | 2cb6e83d-e635-b150-e063-6294a90ad61d | 2025-01-27 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Bryant Ranch Prepack | 1f3c7c37-c488-4a88-8251-7db52dc03827 | 2024-11-04 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Chartwell RX, LLC | a016ab57-d18f-4a3b-b2ab-f91fecc1eef7 | 2024-10-10 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | b54064bc-b3e1-4d83-be40-fcaddd2e99d0 | 2024-08-05 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Patrin Pharma, Inc. | 0fcf5182-a666-4f38-879f-47f19de30dd5 | 2024-05-20 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | American Health Packaging | 5a8f16cc-e5d5-4097-8297-10c8166c7a0e | 2024-02-21 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Strides Pharma Science Limited | 20dad861-6ad1-4660-b315-8af57b294175 | 2023-07-17 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.