Application 207916

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETYLEVACETYLCYSTEINETABLET, EFFERVESCENT;ORAL500MGYesNo
002CETYLEVACETYLCYSTEINETABLET, EFFERVESCENT;ORAL2.5GMYesNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207916-001CETYLEVACETYLCYSTEINE500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29
N207916-002CETYLEVACETYLCYSTEINE2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207916-00187478942032-05-08U-1373Drug product2016-02-08
N207916-00194274212032-05-08Drug product2016-09-23
N207916-00195612042032-05-08U-13732017-03-09
N207916-00287478942032-05-08U-1373Drug product2016-02-08
N207916-00294274212032-05-08Drug product2016-09-23
N207916-00295612042032-05-08U-13732017-03-09

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207916-001CETYLEV500MGTABLET, EFFERVESCENT / ORALRLD2016-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12N207916-002CETYLEV2.5GMTABLET, EFFERVESCENT / ORALRLD2016-01-29782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207916-00187478942032-05-08U-1373Drug product2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-00194274212032-05-08Drug product2016-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-00195612042032-05-08U-13732017-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-00287478942032-05-08U-1373Drug product2016-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-00294274212032-05-08Drug product2016-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207916-00295612042032-05-08U-13732017-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00187478942032-05-08U-1373Drug product2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00194274212032-05-08Drug product2016-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00195612042032-05-08U-13732017-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00287478942032-05-08U-1373Drug product2016-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00294274212032-05-08Drug product2016-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207916-00295612042032-05-08U-13732017-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N207916-00187478942032-05-08U-1373Drug product2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-00194274212032-05-08Drug product2016-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-00195612042032-05-08U-13732017-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-00287478942032-05-08U-1373Drug product2016-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-00294274212032-05-08Drug product2016-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207916-00295612042032-05-08U-13732017-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00187478942032-05-08U-1373Drug product2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00194274212032-05-08Drug product2016-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00195612042032-05-08U-13732017-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00287478942032-05-08U-1373Drug product2016-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00294274212032-05-08Drug product2016-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207916-00295612042032-05-08U-13732017-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00187478942032-05-08U-1373Drug product2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00194274212032-05-08Drug product2016-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00195612042032-05-08U-13732017-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00287478942032-05-08U-1373Drug product2016-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00294274212032-05-08Drug product2016-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207916-00295612042032-05-08U-13732017-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00187478942032-05-08U-1373Drug product2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00194274212032-05-08Drug product2016-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00195612042032-05-08U-13732017-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00287478942032-05-08U-1373Drug product2016-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00294274212032-05-08Drug product2016-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207916-00295612042032-05-08U-13732017-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-00187478942032-05-08U-1373Drug product2016-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-00194274212032-05-08Drug product2016-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-00195612042032-05-08U-13732017-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207916-00287478942032-05-08U-1373Drug product2016-02-082680178bc6a6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetylcysteineACETYLCYSTEINEHospira, Inc.5558a5f5-e821-473b-7d8a-5d33d09f05862026-05-22Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCd50c8ab6-26f8-4669-89d1-c4d26698159a2026-04-11Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECardinal Health 107, LLCc90fca12-12fb-4cf6-bd6f-83bc0d95df812026-04-07Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEEugia US LLC5ae53725-1abb-4122-9c85-f26c2c31566c2025-12-02Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
ACETADOTEACETYLCYSTEINECumberland Pharmaceuticals Inc.472f158a-5ab9-4308-8e49-1116e6ea3d392025-04-30Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEAmerican Regent, Inc.f56b4087-db48-4fd7-84ec-9c927962b8052024-12-17Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC75b48fab-cef6-465c-a1e0-d085b3988bc42024-08-15Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCb8d3ed96-d7ee-43f4-986c-a7d04808711a2024-06-13Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEXellia Pharmaceuticals USA LLC3e2e187e-2445-43b1-b66c-b828e2adf0222023-05-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8cca4e4c-85a2-d575-e053-2995a90a65992022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLCd990ef51-ced2-4359-b99b-092334d2dc9b2022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8d81039e-20ef-5144-e053-2a95a90a89fd2022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticals2324d60b-4f49-4759-a46e-a06bfce7e8aa2022-04-05Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
ACETYLCYSTEINEACETYLCYSTEINEIndoco Remedies Limited6588c28d-0515-4cdf-99d3-c4ad3fd0976c2022-03-01Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-700CetylevacetylcysteineArbor PharmaceuticalsNDACurrent
24338-707CetylevacetylcysteineArbor PharmaceuticalsNDACurrent
24338-725CetylevacetylcysteineArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48066SUPPL2017-04-19
48065SUPPL2017-04-19
45885ORIG2016-11-10
19970ORIG2016-02-11
10624ORIG2016-02-02