FDA.reportPublic FDA data

Application 203624

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETYLCYSTEINEACETYLCYSTEINEINJECTABLE;INTRAVENOUS6GM/30ML (200MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog.

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-193f01610625f2…
2019-09-15 20:21 UTC2019-09A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19ea99ee380514…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203624-001ACETYLCYSTEINE6GM/30ML (200MG/ML)INJECTABLE / INTRAVENOUS2015-06-19cb3db0bc1861…

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