FDA.reportPublic FDA data

Application 072273

Type
ANDA
Sponsor
ARMSTRONG PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROLALBUTEROLAEROSOL, METERED;INHALATION0.09MG/INHNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072273-001ALBUTEROLALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATION1996-08-14

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A072273-001ALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATION1996-08-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072273-001ALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATION1996-08-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072273-001ALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATION1996-08-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072273-001ALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATION1996-08-14a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlbuterolALBUTEROLAmneal Pharmaceuticals NY LLC230d66fc-f62c-42a6-adb3-0a0f879c8ad42026-04-14Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLMylan Pharmaceuticals Inc.9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62026-03-15Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROL SULFATECipla USA Inc.fd0389e0-3713-42e0-8ef2-3bb97676fded2026-01-04Warnings, Adverse reactionsName fallback
brand name: Albuterol
AlbuterolALBUTEROLBryant Ranch Prepack601a18ed-d66e-498f-a804-f1a3330827d42025-04-21Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLRising Pharma Holdings, Inc.40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c2025-03-06Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLZydus Lifesciences Limiteda4709eea-e4a2-46e2-850f-1e6afca018932024-11-25Name fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLZydus Pharmaceuticals USA Inc.c3fa0068-fd12-45de-818e-e929fb45ba052023-08-21Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLAurobindo Pharma Limitedff9b287b-e4a4-4c12-ad2f-6b7d55b20dc62022-12-15Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL
AlbuterolALBUTEROLProficient Rx LP895dff1c-d21c-4470-b021-a5b68364c1ec2022-04-01Warnings, Adverse reactionsName fallback
brand name: Albuterol
generic name: ALBUTEROL

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-198AlbuterolAlbuterolRebel Distributors CorpANDACurrent