Application 018828
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOVIRAX | ACYCLOVIR | CAPSULE;ORAL | 200MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018828-001 | ZOVIRAX | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | RLD | 1985-01-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | RLD | 1985-01-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | AB | RLD | 1985-01-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | RLD | 1985-01-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | AB | RLD | 1985-01-25 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018828-001 | ZOVIRAX | 200MG | CAPSULE / ORAL | AB | RLD | 1985-01-25 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018828-001 | ZOVIRAX | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1985-01-25 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N018828-001 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | N018828-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018828-001 | AB | 1 | ea99ee380514… |
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 suspension | ACYCLOVIR | Novadoz Pharmaceuticals LLC | 3efa1e5e-5a14-4724-a2ca-25702f10faed | 2023-11-03 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | A-S Medication Solutions | 942632d8-08cd-4003-aec0-1c6d5c09bc15 | 2023-07-24 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | SQUARE PHARMACEUTICALS LIMITED | b24201ea-aeae-4de1-b01b-eee89068e786 | 2023-07-02 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | e8433261-07f1-448b-aaf4-631414598c08 | 2023-05-08 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | A-S Medication Solutions | c40a57b9-4cf1-4a69-abf3-eb99a7fcda00 | 2023-04-16 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | 34a38cdf-04e8-4006-a9f5-4a0831117d61 | 2023-02-06 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Modavar Pharmaceuticals LLC | 8de9c4f3-b800-4419-a063-8b62a0cba0fa | 2022-12-29 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Quinn Pharmaceuticals | 9ad711e4-003d-4b58-8177-32928bc42aa9 | 2022-12-20 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | PharmPak, Inc. | d824fc07-9f03-4cb2-9bf8-ff7cc2955255 | 2022-10-09 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | PharmPak, Inc. | 8fb01f23-e2bd-6850-e053-2995a90a7cc5 | 2022-10-09 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Viona Pharmaceuticals Inc | 12df1991-fb1c-45df-acf3-706b1e8ecfc3 | 2022-10-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Camber Pharmaceuticals, Inc. | 2ca1395f-96b4-4543-8eed-bd07c62bbc7c | 2022-09-12 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | e8056ec6-d2dc-48af-8550-82726af1c5c5 | 2022-08-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 9e5b3a11-9c4b-4998-8a18-3046af1314ab | 2022-06-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 33630a35-346e-43b6-9286-89e28ac0094a | 2022-06-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | c55bde35-a202-4c25-b545-e5d5e95c1175 | 2022-04-01 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Proficient Rx LP | 32aa3f42-23a1-4867-8228-e6e76cf9f135 | 2022-02-01 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Zydus Pharmaceuticals (USA) Inc. | 69a98000-adef-4323-89a7-09e035a257d4 | 2021-11-29 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Solco Healthcare US, LLC | a1d7b8ec-309d-447e-ae05-b9e89cc29948 | 2021-11-15 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Macleods Pharmaceuticals Limited | d42fce5a-9ea3-4058-a3ba-4c18a6024160 | 2021-08-24 | Warnings, Adverse reactions | ACYCLOVIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.