FDA.reportPublic FDA data

Application 078921

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANASTROZOLEANASTROZOLETABLET;ORAL1MGNoNo

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
A078921-001ANASTROZOLEANASTROZOLE1MGTABLET / ORALAB2010-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078921-001AB

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 22:54:322026-06A078921-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078921-001AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnastrozoleANASTROZOLEBryant Ranch Prepackf5b53383-0366-4ae2-9aa4-88b56c0bbd072026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEAmerican Health Packagingdface914-5135-4136-82f4-75429b496a352025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
ndc (product): 60687-112
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.b023a9f2-1a99-4b40-a953-edac7e3a79bf2025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEBluePoint Laboratories3cd04ed6-7c5a-4c4a-9955-ee40839dfea02025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
ndc (product): 68001-155
AnastrozoleANASTROZOLEZydus Pharmaceuticals USA Inc.ca16f8de-d9a5-4c6c-957b-ae28497b67ac2025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
ndc (product): 68382-209
AnastrozoleANASTROZOLEZydus Lifesciences Limited965c4cb1-f6b8-47ac-bf13-c36639aa908f2024-11-25Exact identifier
application applno (ANDA): 078921
application number: ANDA078921
ndc (product): 65841-743

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
65841-743AnastrozoleAnastrozoleCadila Healthcare LimitedANDACurrent
65841-743AnastrozoleAnastrozoleCadila Healthcare LimitedANDACurrent
65841-743AnastrozoleAnastrozoleZydus Lifesciences LimitedANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68382-209AnastrozoleAnastrozoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-209AnastrozoleAnastrozoleZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9197ORIG2010-06-30