FDA.reportPublic FDA data

Application 072152

Type
ANDA
Sponsor
YAOPHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo

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
2019-12-13 00:20 UTC2019-12A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-053f01610625f2…
2019-09-15 20:21 UTC2019-09A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A072152-001ALBUTEROL SULFATEEQ 4MG BASETABLET / ORAL1989-12-05ea99ee380514…

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
albuterol sulfateALBUTEROL SULFATEPadagis Israel Pharmaceuticals Ltd489201d2-9ed0-419b-81dc-a7f7f86b59ed2024-09-30Warnings, Adverse reactionsName fallback
brand name: albuterol sulfate
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack45e07bdd-78f9-4055-9de3-646e67de7eaf2024-08-15Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATELuoxin Aurovitas Pharma (Chengdu) Co., Ltd.1d6be2b8-c670-b783-e063-6294a90ae5032024-07-31Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma Limited78e6bee2-7113-46cf-8c97-dc61b0f7b94f2024-07-31Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packagingb0f73459-baeb-42a7-be48-2c3647d9b2052024-07-30Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol sulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.b478d9e9-9704-6af2-e053-2995a90aafd42024-07-17Warnings, Adverse reactionsName fallback
brand name: Albuterol sulfate
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.7043bc12-8a58-8ff8-e053-2a91aa0ab6272024-07-16Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.54d90668-5237-4330-e054-00144ff88e882024-07-15Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.8c278b6f-d32b-b750-e053-2995a90ad7e92024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaa6d5c00-46a5-4f93-95e4-09319abfe71e2024-05-07Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions19867b61-77a2-46f1-97c7-7fadfec5882b2024-05-07Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaff836e4-34f2-4ab9-bbf8-0c41ac848cb02024-05-07Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFAALBUTEROL SULFATEPrasco Laboratoriesb25d9d6b-eb4c-452e-89ef-10e611deebd62024-04-30Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATEGlaxoSmithKline LLCd92c5d6b-ff10-4087-36a2-1cfc464cb9672024-04-26Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirst767a1504-1e04-1e06-e053-2a91aa0aa4b62024-02-22Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC.7f261a9b-65d9-408a-8609-c1b3809b8b4b2024-02-21Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC4e48ccbe-3ec0-4bf2-be28-83eb9baa63d62024-02-21Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC922bf33b-4d55-4c35-9f68-72efbb17c14f2024-02-21Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEA-S Medication Solutions7ad17b39-d2de-4108-abbf-cedd650c8edd2024-02-18Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFAALBUTEROL SULFATEAsclemed USA, Inc.a69489f7-4ffb-4cd1-b2d2-002f48e84f512023-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE

Reported adverse events (FAERS/openFDA)#

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