FDA.reportPublic FDA data

Application 207625

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.0103% BASENoNo
002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.021% BASENoNo
003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.042% BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207625-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-12-30
A207625-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-12-30
A207625-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207625-001AN
A207625-002AN
A207625-003AN

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
2026-08-01 22:54:322026-06A207625-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONAN2016-12-30a50c72e98297…
2026-08-01 22:54:322026-06A207625-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONAN2016-12-30a50c72e98297…
2026-08-01 22:54:322026-06A207625-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONAN2016-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207625-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A207625-002AN1a50c72e98297…
2026-08-01 22:54:322026-06A207625-003AN1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevalbuterolLEVALBUTEROLLuoxin Aurovitas Pharma (Chengdu) Co., Ltd.29eae75d-93da-7a5a-e063-6394a90ac0c02024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207625
application number: ANDA207625
LevalbuterolLEVALBUTEROLAurobindo Pharma Limited5f1c4f22-d420-495c-8f64-33532638215f2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207625
application number: ANDA207625
ndc (product): 65862-944
ndc (product): 65862-945
ndc (product): 65862-943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65862-943LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-943LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-943LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-943LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-944LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-944LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-944LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-944LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-945LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-945LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-945LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent
65862-945LevalbuterolLevalbuterolAurobindo Pharma LimitedANDACurrent