FDA.reportPublic FDA data

Application 074848

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPOFOLPROPOFOLINJECTABLE;INJECTION10MG/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
A074848-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2005-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074848-001AB

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 22:54:322026-06A074848-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2005-04-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074848-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLHikma Pharmaceuticals USA Inc.fdb77e13-f5a7-4c4a-9f8e-338b702239c82022-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074848
application number: ANDA074848
ndc (product): 0641-6194
ndc (product): 0641-6196
ndc (product): 0641-6195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6194PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6194PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6195PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6195PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6196PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6196PropofolPropofolHikma Pharmaceuticals USA Inc.ANDACurrent
70518-3256PropofolPropofolREMEDYREPACK INC.ANDACurrent
72572-583PropofolPropofolCivica, Inc.ANDACurrent
72572-584PropofolPropofolCivica, Inc.ANDACurrent
72572-585PropofolPropofolCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44248ORIG2007-06-18
8457ORIG2005-04-28