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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2022-09-29 23:25 UTC | 2022-09 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N203791-001 | SITAVIG | 50MG | TABLET / BUCCAL | RLD, RS | 2013-04-12 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203791-001 | 8747896 | 2027-06-03 | U-1460 | Drug product | 2014-07-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203791-001 | 8592434 | 2030-06-16 | U-1460 | Drug product | 2013-12-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N203791-001 | 8791127 | 2027-03-23 | U-1460 | Drug product | 2014-08-06 | 8072bd15b7f6… |
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 | Preferred Pharmaceuticals, Inc. | b6d69697-12bb-4548-a6c3-2463cbf54f8f | 2026-02-11 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | 2e6a3667-af06-40de-80c0-8c4346e0671f | 2026-02-08 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | American Health Packaging | 05f42300-2a06-45f1-a9b9-6e5c84ae58ec | 2026-02-04 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Camber Pharmaceuticals, Inc. | 0910335b-6796-459f-b97e-d7ef5439a060 | 2026-02-02 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Glenmark Pharmaceuticals Inc., USA | 149f4418-7668-4d34-a6f9-69bf3a9c5049 | 2026-01-28 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | ANI Pharmaceuticals, Inc. | 8208711c-18ba-4615-b932-3c0bb7e6efae | 2026-01-23 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Actavis Pharma, Inc. | a4c1305c-f18c-4fb0-83d8-2822341f2dfa | 2026-01-21 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Preferred Pharmaceuticals Inc | 75334fc5-d236-401a-875c-f4f9c7749c1a | 2026-01-19 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Preferred Pharmaceuticals Inc | c11c1136-7421-48ff-86d2-39507e80a04c | 2026-01-15 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Preferred Pharmaceuticals Inc. | b1033fda-8242-4006-b1cd-23474d70671f | 2026-01-15 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | AvPAK | 6e203fa9-ee97-1e08-8d6a-fb57cfa13e19 | 2026-01-08 | Warnings, Adverse reactions | ACYCLOVIR |
| Avaclyr | ACYCLOVIR | Fera Pharmaceuticals, LLC | 3ce26231-bc40-48b0-85e5-2e7622f334d7 | 2026-01-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Cadila Pharmaceuticals Limited | dbaf4bf5-57e3-4770-a9b2-d47649e54c1b | 2026-01-02 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Northwind Health Company, LLC | 5dcfd21c-43f0-469c-be70-a4e74e6ccf88 | 2026-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Northwind Health Company, LLC | f6f56143-ea74-af87-e053-6394a90ae346 | 2026-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | Northwind Health Company, LLC | ff9776b3-a248-e1ea-e053-6294a90aeb7b | 2026-01-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | YILING PHARMACEUTICAL, INC. | 67e7b340-0635-2595-e053-2a91aa0ad266 | 2025-12-30 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | YILING PHARMACEUTICAL, INC. | 8542495c-eef1-448b-abb5-83cb1ac589f7 | 2025-12-30 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | YILING PHARMACEUTICAL, INC. | 677edfd5-2d04-b932-e053-2a91aa0a26b0 | 2025-12-30 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Chartwell Governmental & Specialty RX, LLC. | 2757bb30-3374-4e1b-b496-14874f7ec623 | 2025-12-23 | Warnings, Adverse reactions | ACYCLOVIR |
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 |