Application 210774
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACYCLOVIR | ACYCLOVIR | OINTMENT;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210774-001 | ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 |
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 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | 2019-09-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | b00525d2431f… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A210774-001 | ACYCLOVIR | 5% | OINTMENT / TOPICAL | AB | 2019-09-06 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210774-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210774-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210774-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210774-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210774-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210774-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210774-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210774-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210774-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210774-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210774-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210774-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210774-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210774-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210774-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210774-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210774-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A210774-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A210774-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A210774-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A210774-001 | AB | 1 | b00525d2431f… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210774-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210774-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210774-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210774-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210774-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210774-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210774-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210774-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210774-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210774-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A210774-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A210774-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210774-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Acyclovir | ACYCLOVIR | Redpharm Drug | 53cbca4d-3ddc-b11e-e063-6394a90a04fa | 2026-06-09 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | St. Mary's Medical Park Pharmacy | 1493e22d-455d-b613-e063-6294a90afede | 2026-06-04 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4 | 2026-06-04 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0 | 2026-05-27 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Bryant Ranch Prepack | 2b600b5d-ce91-461f-b9d1-75b969daf8e9 | 2026-05-21 | Warnings, Adverse reactions | ACYCLOVIR ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 0e78d5e8-ae2d-4e84-b8c2-6765b1299c12 | 2026-05-21 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Westminster Pharmaceuticals, LLC | f352a641-988e-4878-8016-2b69cd6ee548 | 2026-05-11 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir suspension | ACYCLOVIR | Atlantic Biologicals Corp. | 5105272f-cff8-8898-e063-6394a90aabb5 | 2026-05-04 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Torrent Pharmaceuticals Limited | 1c510390-fb00-4271-967d-0883a9d5e1fd | 2026-05-04 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Aryeh Pharma Corp | f60cc0c2-e0fe-406a-b5c0-90bc4b566bb3 | 2026-05-01 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | Proficient Rx LP | d4729677-164b-41b8-bbc4-4e47346b0f72 | 2026-05-01 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8 | 2026-04-29 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 0990b625-5dfe-4810-b5b4-ac5948599e79 | 2026-04-27 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | Sportpharm LLC | c561bf77-5b26-4f23-9d49-9d964b48f772 | 2026-04-24 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Modavar Pharmaceuticals LLC | c7317324-4654-4bcc-8edf-7b7cd8794d2e | 2026-04-24 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Cardinal Health 107, LLC | d8004652-86fe-4714-81d4-5e1dd2585bb4 | 2026-04-20 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | Northstar Rx LLC | 6788f3c6-b79c-4f3f-9a73-10c8d3a38267 | 2026-04-17 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 960e4ede-692e-4db2-a96e-dc6f4a6190ee | 2026-04-03 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| acyclovir | ACYCLOVIR | A-S Medication Solutions | a0ed999f-7366-42c3-a6f5-3c239215a99c | 2026-03-27 | Warnings, Adverse reactions | acyclovir ACYCLOVIR |
| Acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | c2d9940a-ce88-5fd0-e053-2a95a90a4bc8 | 2026-03-26 | Warnings, Adverse reactions | Acyclovir ACYCLOVIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.