FDA.reportPublic FDA data

Application 089903

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEINJECTABLE;INJECTIONEQ 5MG BASE/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
A089903-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP1989-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089903-001AP

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 22:54:322026-06A089903-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP1989-08-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A089903-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHikma Pharmaceuticals USA Inc.baf59816-7577-4652-b065-fb6de9e545692025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089903
application number: ANDA089903
ndc (product): 0641-6135
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECivica, Inc.e3e0c6c5-6b92-40e0-a926-29c64846be932025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089903
application number: ANDA089903
ndc (product): 72572-580
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEHF Acquisition Co LLC, DBA HealthFirste181c18d-32a8-587e-e053-2995a90acc5b2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089903
application number: ANDA089903
ndc (product): 51662-1558

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-0491Prochlorperazine EdisylateProchlorperazine EdisylateBaxter Healthcare CorporationANDACurrent
0641-6135Prochlorperazine EdisylateProchlorperazine EdisylateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6135Prochlorperazine EdisylateProchlorperazine EdisylateWest-Ward Pharmaceuticals Corp.ANDACurrent
51662-1558PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
72572-580Prochlorperazine EdisylateProchlorperazine EdisylateCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53905ORIG2018-05-01
39606SUPPL2013-01-09