FDA.reportPublic FDA data

Application 040516

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATETABLET;ORAL500MGNoNo

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

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
A040516-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2003-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040516-001AA

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 22:54:322026-06A040516-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2003-08-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040516-001AA1a50c72e98297…

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
Chloroquine PhosphateCHLOROQUINE PHOSPHATEAvKARE0a342f72-45f9-3e12-e063-6394a90ae33e2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040516
application number: ANDA040516
Chloroquine PhosphateCHLOROQUINE PHOSPHATEAmneal Pharmaceuticals of New York LLCeb02c52d-907c-43fb-aa8f-2f378a9087e72025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040516
application number: ANDA040516
ndc (product): 0115-7010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-7010Chloroquine PhosphateCHLOROQUINE PHOSPHATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7010Chloroquine PhosphateCHLOROQUINE PHOSPHATEAmneal Pharmaceuticals of New York LLCANDACurrent