Application 202408
- Type
- NDA
- Sponsor
- FERA PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVACLYR | ACYCLOVIR | OINTMENT;OPHTHALMIC | 3% | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202408-001 | AVACLYR | ACYCLOVIR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N202408-001 | ODE-235 | 2026-03-29 |
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| 2026-08 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N202408-001 | AVACLYR | 3% | OINTMENT / OPHTHALMIC | RLD, RS | 2019-03-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N202408-001 | AVACLYR | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD | 2019-03-29 | f41ea6bd6efb… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202408-001 | ODE-235 | 2026-03-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202408-001 | ODE-235 | 2026-03-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202408-001 | ODE-235 | 2026-03-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202408-001 | ODE-235 | 2026-03-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202408-001 | ODE-235 | 2026-03-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202408-001 | ODE-235 | 2026-03-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202408-001 | ODE-235 | 2026-03-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202408-001 | ODE-235 | 2026-03-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202408-001 | ODE-235 | 2026-03-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202408-001 | ODE-235 | 2026-03-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202408-001 | ODE-235 | 2026-03-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202408-001 | ODE-235 | 2026-03-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202408-001 | ODE-235 | 2026-03-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202408-001 | ODE-235 | 2026-03-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202408-001 | ODE-235 | 2026-03-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202408-001 | ODE-235 | 2026-03-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202408-001 | ODE-235 | 2026-03-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202408-001 | ODE-235 | 2026-03-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202408-001 | ODE-235 | 2026-03-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N202408-001 | ODE-235 | 2026-03-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N202408-001 | ODE-235 | 2026-03-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202408-001 | ODE-235 | 2026-03-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202408-001 | ODE-235 | 2026-03-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202408-001 | ODE-235 | 2026-03-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202408-001 | ODE-235 | 2026-03-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202408-001 | ODE-235 | 2026-03-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202408-001 | ODE-235 | 2026-03-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202408-001 | ODE-235 | 2026-03-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202408-001 | ODE-235 | 2026-03-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202408-001 | ODE-235 | 2026-03-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202408-001 | ODE-235 | 2026-03-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202408-001 | ODE-235 | 2026-03-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202408-001 | ODE-235 | 2026-03-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202408-001 | ODE-235 | 2026-03-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202408-001 | ODE-235 | 2026-03-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202408-001 | ODE-235 | 2026-03-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202408-001 | ODE-235 | 2026-03-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202408-001 | ODE-235 | 2026-03-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202408-001 | ODE-235 | 2026-03-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202408-001 | ODE-235 | 2026-03-29 | 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 |
|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | REMEDYREPACK INC. | c1744e01-0e40-4851-8ffc-c3bf29dd7c2b | 2026-08-31 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | NuCare Pharmaceuticals, Inc. | 5176c7f9-9076-4797-e054-00144ff8d46c | 2026-08-27 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | e5e99a6b-79a6-7fdb-e053-2a95a90a8563 | 2026-08-26 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | 58dc1402-6098-9cb3-e063-6294a90a062b | 2026-08-19 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Northwind Health Company, LLC | 50c58161-3944-7367-e063-6394a90a6286 | 2026-08-19 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Cardinal Health 107, LLC | 4cc7d67f-35fa-4238-a581-4810645083cf | 2026-08-13 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | c | 59007780-d736-4195-a204-7f85a709ed46 | 2026-08-12 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 0de2f5c7-9e75-4bdf-9c28-e026cc6694b4 | 2026-07-24 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | 86c43bdf-c5bf-47cd-8dfd-811263825878 | 2026-07-24 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 6d0e492e-5359-49e8-812d-8c8e2e5d42f8 | 2026-07-24 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 736679be-469e-4bdb-8e15-b10751c3dd60 | 2026-07-24 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 38547daa-7d2f-4a7b-84d3-6e164984f958 | 2026-07-17 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Major Pharmaceuticals | 9b254eed-8ea1-469b-bf27-f5670cd99e8d | 2026-07-14 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | ATLANTIC BIOLOGICALS CORP. | da5a809c-6ddc-4609-9a34-ccb3d2d43976 | 2026-07-10 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 85332671-0e3a-4445-a337-e1266886b9cf | 2026-07-08 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | American Health Packaging | 05f42300-2a06-45f1-a9b9-6e5c84ae58ec | 2026-07-01 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 499c6a98-0614-4ded-8526-909942bae8a4 | 2026-06-26 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 37a51d9c-1f39-4065-8c7d-6528ac6de91c | 2026-06-23 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Alembic Pharmaceuticals Inc. | 878615c2-09ea-44ce-8c30-7a7f16acb20c | 2026-06-18 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Bryant Ranch Prepack | db35fce0-d7a3-4589-ba60-d78cdb1119cb | 2026-06-18 | Warnings, Adverse reactions | ACYCLOVIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.