FDA.reportPublic FDA data

Application 080515

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CYANOCOBALAMINCYANOCOBALAMININJECTABLE;INJECTION1MG/MLNoNo

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
A080515-002CYANOCOBALAMINCYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080515-002AP

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 22:54:322026-06A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080515-002AP1a50c72e98297…

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
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst953aa8c6-31ce-0c3b-e053-2a95a90ab35f2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080515
application number: ANDA080515
ndc (product): 51662-1394
CyanocobalaminCYANOCOBALAMINHikma Pharmaceuticals USA Inc.a66eb3c4-3e1d-4d49-b963-4fa2334cc9b62023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080515
application number: ANDA080515
ndc (product): 0143-9621
ndc (product): 0143-9619
ndc (product): 0143-9620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9619CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9619CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9620CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9620CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9621CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9621CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
50090-2709CyanocobalamincyanocobalaminA-S Medication SolutionsANDACurrent
50090-2709CyanocobalamincyanocobalaminA-S Medication SolutionsANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22636ORIG2003-08-04