FDA.reportPublic FDA data

Application 071295

Type
ANDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINEATROPINESOLUTION;INTRAMUSCULAREQ 2MG SULFATE/0.7MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A071295-001ATROPINEATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULAR1987-01-30

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071295-001ATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULAR1987-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071295-001ATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULAR1987-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071295-001ATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULAR1987-01-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071295-001ATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULAR1987-01-30a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsName fallback
brand name: Atropine
AtropineATROPINE SULFATEApotex Corp.127a7e32-a150-01d6-a66a-b7708d85809f2026-03-10Warnings, Adverse reactionsName fallback
brand name: Atropine
ATROPINEATROPINE SULFATEA-S Medication Solutionsb4736dbc-b7c8-4b33-b7a8-a47c5654a1272026-02-10Warnings, Adverse reactionsName fallback
brand name: ATROPINE
AtropineATROPINE SULFATERedpharm Drug46e98d0b-3a04-7feb-e063-6394a90ac75e2025-12-27Warnings, Adverse reactionsName fallback
brand name: Atropine
AtropineATROPINE SULFATEAmneal Pharmaceuticals NY LLCf8718be5-8fa4-4c36-a4fd-fac7c3953f5a2025-12-04Warnings, Adverse reactionsName fallback
brand name: Atropine
AtropineATROPINE SULFATEA-S Medication Solutions1b2d030e-c0ec-484b-a228-76011702cdd02024-01-02Warnings, Adverse reactionsName fallback
brand name: Atropine
ATROPEN Auto-InjectorATROPINEMeridian Medical Technologies LLCe2d4307d-da8f-49f5-aac0-02355dd9ffb72022-09-15Warnings, Adverse reactionsName fallback
generic name: ATROPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.