Application 207916

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETYLEV	ACETYLCYSTEINE	TABLET, EFFERVESCENT;ORAL	500MG	Yes	No
002	CETYLEV	ACETYLCYSTEINE	TABLET, EFFERVESCENT;ORAL	2.5GM	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207916-001	CETYLEV	ACETYLCYSTEINE	500MG	TABLET, EFFERVESCENT / ORAL		RLD	2016-01-29
N207916-002	CETYLEV	ACETYLCYSTEINE	2.5GM	TABLET, EFFERVESCENT / ORAL		RLD	2016-01-29

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08
N207916-001	9427421	2032-05-08		Drug product	2016-09-23
N207916-001	9561204	2032-05-08	U-1373		2017-03-09
N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08
N207916-002	9427421	2032-05-08		Drug product	2016-09-23
N207916-002	9561204	2032-05-08	U-1373		2017-03-09

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207916-001	CETYLEV	500MG	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207916-002	CETYLEV	2.5GM	TABLET, EFFERVESCENT / ORAL	RLD	2016-01-29	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207916-002	9427421	2032-05-08		Drug product	2016-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207916-002	9561204	2032-05-08	U-1373		2017-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207916-001	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207916-001	9427421	2032-05-08		Drug product	2016-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207916-001	9561204	2032-05-08	U-1373		2017-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207916-002	8747894	2032-05-08	U-1373	Drug product	2016-02-08	`fd3edfee7708…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetylcysteine	ACETYLCYSTEINE	Hospira, Inc.	5558a5f5-e821-473b-7d8a-5d33d09f0586	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Glenmark Pharmaceuticals Inc., USA	f811ddfc-d7c1-4637-ae81-80c38a77cb80	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Somerset Therapeutics, LLC	d50c8ab6-26f8-4669-89d1-c4d26698159a	2026-04-11	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Cardinal Health 107, LLC	c90fca12-12fb-4cf6-bd6f-83bc0d95df81	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Eugia US LLC	5ae53725-1abb-4122-9c85-f26c2c31566c	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Sagent Pharmaceuticals	c206c659-16ea-444a-8c60-8a3343400ada	2025-10-26	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	ONESOURCE SPECIALTY PHARMA LIMITED	3b0310d2-4e70-4b94-8d69-cb5999a32b54	2025-09-12	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Hikma Pharmaceuticals USA Inc.	277963a0-8ab2-4305-a688-28e47e87c584	2025-09-09	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Cameron Pharmaceuticals	8165ad85-98e7-438f-9567-5cfda88d0ebf	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
acetylcysteine	ACETYLCYSTEINE	Padagis US LLC	9d305722-e74f-4f48-8d2c-0daa99144749	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
ACETADOTE	ACETYLCYSTEINE	Cumberland Pharmaceuticals Inc.	472f158a-5ab9-4308-8e49-1116e6ea3d39	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	American Regent, Inc.	f56b4087-db48-4fd7-84ec-9c927962b805	2024-12-17	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	75b48fab-cef6-465c-a1e0-d085b3988bc4	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Somerset Therapeutics, LLC	b8d3ed96-d7ee-43f4-986c-a7d04808711a	2024-06-13	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Xellia Pharmaceuticals USA LLC	3e2e187e-2445-43b1-b66c-b828e2adf022	2023-05-31	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	8cca4e4c-85a2-d575-e053-2995a90a6599	2022-10-31	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	d990ef51-ced2-4359-b99b-092334d2dc9b	2022-10-31	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	8d81039e-20ef-5144-e053-2a95a90a89fd	2022-10-31	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
Acetylcysteine	ACETYLCYSTEINE	Sagent Pharmaceuticals	2324d60b-4f49-4759-a46e-a06bfce7e8aa	2022-04-05	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE
ACETYLCYSTEINE	ACETYLCYSTEINE	Indoco Remedies Limited	6588c28d-0515-4cdf-99d3-c4ad3fd0976c	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: ACETYLCYSTEINE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-700	Cetylev	acetylcysteine	Arbor Pharmaceuticals	NDA	Current
24338-707	Cetylev	acetylcysteine	Arbor Pharmaceuticals	NDA	Current
24338-725	Cetylev	acetylcysteine	Arbor Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48066	SUPPL	2017-04-19
48065	SUPPL	2017-04-19
45885	ORIG	2016-11-10
19970	ORIG	2016-02-11
10624	ORIG	2016-02-02