Application 203791
- Type
- NDA
- Sponsor
- EPI HLTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SITAVIG | ACYCLOVIR | TABLET;BUCCAL | 50MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203791-001 | SITAVIG | ACYCLOVIR | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 |
| N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 |
| N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 |
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 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD | 2013-04-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 301d65b070ca… |
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 | 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 |
| Acyclovir | ACYCLOVIR | Amneal Pharmaceuticals LLC | 9167ea4a-959d-402c-96b4-619395821c01 | 2021-07-23 | Warnings, Adverse reactions | ACYCLOVIR |
| Zovirax | ACYCLOVIR | Bausch Health US, LLC | 125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2 | 2021-02-01 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Proficient Rx LP | 3da54b2d-a206-4ff5-8cc2-90762c4fd70d | 2021-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Proficient Rx LP | 4c5a75fa-73db-4f48-895f-de1635d33f49 | 2021-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | Proficient Rx LP | 8d7994a6-5bd2-494d-89c1-b03755d4f2c3 | 2020-12-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | ACTAVIS PHARMA, INC. | b360a808-a24d-4f3c-89a7-9941422d17d6 | 2020-10-31 | Warnings, Adverse reactions | ACYCLOVIR |
| Zovirax | ACYCLOVIR | Bausch Health US, LLC | 50278e0e-da1e-45ee-9fcb-672b2a219911 | 2020-10-31 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Asclemed USA, Inc. | e186fdc9-b60e-4280-8d60-36cae9f2838f | 2020-09-25 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Proficient Rx LP | 51052f0e-1a07-405a-a962-981ce9439e02 | 2020-02-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Xiromed, LLC | 3e222423-3bf2-6584-6d54-447b1b26dc42 | 2020-01-30 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 6714cfd9-97d3-4290-b618-54594d89cf4e | 2020-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68712-049 | Sitavig | Acyclovir | Cipher Pharmaceuticals US LLC | NDA | Current |
| 71403-049 | Sitavig | Acyclovir | EPI Health, Inc | NDA | Current |
| 71403-049 | Sitavig | Acyclovir | EPI Health, Inc | NDA | Current |
| 71403-049 | Sitavig | Acyclovir | EPI Health, Inc | NDA | Current |