Application 203791

Type: NDA
Sponsor: EPI HLTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SITAVIG	ACYCLOVIR	TABLET;BUCCAL	50MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
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.

Matched openFDA labels page 2 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	2b600b5d-ce91-461f-b9d1-75b969daf8e9	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Westminster Pharmaceuticals, LLC	f352a641-988e-4878-8016-2b69cd6ee548	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir suspension	ACYCLOVIR	Atlantic Biologicals Corp.	5105272f-cff8-8898-e063-6394a90aabb5	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Torrent Pharmaceuticals Limited	1c510390-fb00-4271-967d-0883a9d5e1fd	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Aryeh Pharma Corp	f60cc0c2-e0fe-406a-b5c0-90bc4b566bb3	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Proficient Rx LP	d4729677-164b-41b8-bbc4-4e47346b0f72	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	0990b625-5dfe-4810-b5b4-ac5948599e79	2026-04-27	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Sportpharm LLC	c561bf77-5b26-4f23-9d49-9d964b48f772	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	c7317324-4654-4bcc-8edf-7b7cd8794d2e	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	Cardinal Health 107, LLC	d8004652-86fe-4714-81d4-5e1dd2585bb4	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	Northstar Rx LLC	6788f3c6-b79c-4f3f-9a73-10c8d3a38267	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	960e4ede-692e-4db2-a96e-dc6f4a6190ee	2026-04-03	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
acyclovir	ACYCLOVIR	A-S Medication Solutions	a0ed999f-7366-42c3-a6f5-3c239215a99c	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: ACYCLOVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61390	SUPPL	2019-12-23
61351	SUPPL	2019-12-19
24449	ORIG	2014-01-07
22935	ORIG	2014-01-07
40327	ORIG	2013-04-16
32466	ORIG	2013-04-16