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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.bb538b7d-e390-419a-9404-a57c1db4a4472026-04-09Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATECardinal Health 107, LLC6ec88f64-66a2-4ca9-9913-c192fc33f88b2026-04-08Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation285a656c-f77f-4e77-b0a8-a0e9c901803f2026-04-06Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
albuterol sulfateALBUTEROL SULFATESun Pharmaceutical Industries, Inc.87b8cd3c-2849-4b50-b63e-9ea379165c072026-03-16Warnings, Adverse reactionsName fallback
brand name: albuterol sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.c90e80b2-882e-4c0c-bfac-d67eb1da724d2026-02-16Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEMylan Pharmaceuticals Inc.5329614f-ae0b-4854-bb6f-ea0b7dae87c02026-02-10Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol Sulate HFAALBUTEROL SULFATEREMEDYREPACK INC.77d34a3c-ccc6-420a-ad31-a1af55f7de762026-01-30Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.1f0bf143-66d4-4a39-b2d1-a5c460ffdcf92026-01-22Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATEREMEDYREPACK INC.2ed73618-be3a-4331-9509-6401258f791f2026-01-19Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.5de6a189-a8b7-4b33-b162-add6b6e4b2752026-01-16Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.d6acb5a7-555a-463a-ae65-2911d6789b422026-01-14Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
AlbuterolALBUTEROL SULFATECipla USA Inc.fd0389e0-3713-42e0-8ef2-3bb97676fded2026-01-04Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell Governmental & Specialty RX, LLC.dd47559a-84f6-42a5-a00e-48754505418e2025-12-17Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack378461f2-7271-44a3-9da3-b39970b65d3a2025-11-10Warnings, Adverse reactionsName fallback
brand name: ALBUTEROL SULFATE
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation574824f3-51cc-4b94-9c10-e3204d8b19f82025-11-07Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEASCLEMED USA INC.8ea40065-4f59-434f-9ea1-7ef006fde66e2025-11-07Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.056e145b-87aa-4009-a7ab-2ac0bd086eb02025-11-06Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.2c3f975c-dbd8-0362-e063-6394a90a16dd2025-10-21Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.4120061a-dbae-8918-e063-6394a90afbf22025-10-14Warnings, Adverse reactionsName fallback
brand name: Albuterol Sulfate
generic name: ALBUTEROL SULFATE

Reported adverse events (FAERS/openFDA)#

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