Application 209347

Type: NDA
Sponsor: EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GANZYK-RTU	GANCICLOVIR	SOLUTION;INTRAVENOUS	500MG/250ML (2MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N209347-001	GANZYK-RTU	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS		RLD	2017-02-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209347-001	9486530	2034-09-02		Drug product	2017-04-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209347-001	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209347-001	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIRGAN	GANCICLOVIR	Bausch & Lomb Incorporated	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: GANCICLOVIR
Ganciclovir	GANCICLOVIR	Endo USA, Inc.	87afd103-6e64-444f-971d-0e732e9ae995	2020-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GANCICLOVIR

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-2500	GANCICLOVIR	GANCICLOVIR	EXELA PHARMA SCIENCES, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52673	ORIG	2018-02-20
49865	SUPPL	2017-09-27
49835	SUPPL	2017-09-22
47266	ORIG	2017-02-21
47265	ORIG	2017-02-21