FDA.reportPublic FDA data

Application 217625

Type
ANDA
Sponsor
STIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZINC CHLORIDEZINC CHLORIDEINJECTABLE;INJECTIONEQ 1MG ZINC/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
A217625-001ZINC CHLORIDEZINC CHLORIDEEQ 1MG ZINC/MLINJECTABLE / INJECTIONAP2025-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217625-001AP

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
2026-02-19 14:30 UTC2026-02A217625-001ZINC CHLORIDEEQ 1MG ZINC/MLINJECTABLE / INJECTIONAP2025-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217625-001ZINC CHLORIDEEQ 1MG ZINC/MLINJECTABLE / INJECTIONAP2025-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A217625-001ZINC CHLORIDEEQ 1MG ZINC/MLINJECTABLE / INJECTIONAP2025-04-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217625-001ZINC CHLORIDEEQ 1MG ZINC/MLINJECTABLE / INJECTIONAP2025-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217625-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217625-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217625-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217625-001AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc ChlorideZINC CHLORIDEExela Pharma Sciences,LLC2bd646d2-2a2a-4376-8da0-c7f08b0511ac2026-08-03Warnings, Adverse reactionsName fallback
brand name: Zinc Chloride
generic name: ZINC CHLORIDE
ZINCZINC CHLORIDEHospira, Inc.9a1914a0-e195-4233-c1be-bc2075580eb82026-05-13Warnings, Adverse reactionsName fallback
generic name: ZINC CHLORIDE
BM Zinc chloride (Zinc Mur)ZINC CHLORIDEBM Private Limited38047827-0a8a-8252-e063-6294a90aeebb2025-12-02WarningsName fallback
generic name: ZINC CHLORIDE
Bestmade Natural Products Zinc Chloride (Zinc Mur)ZINC CHLORIDEBestmade Natural Products2fadb4c6-9f66-f4fd-e063-6394a90a14f22025-05-26WarningsName fallback
generic name: ZINC CHLORIDE
Zinc ChlorideZINC CHLORIDESomerset Therapeutics, LLC9a4f7a7b-26d0-4292-bc7b-6ca9fa48600f2024-10-17Warnings, Adverse reactionsName fallback
brand name: Zinc Chloride
generic name: ZINC CHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81197ORIG 2025-02-10