Home Applications 012699 Application 012699
Type NDA
Sponsor GD SEARLE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE SOLUTION;ORAL 0.025MG/5ML;2.5MG/5ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012699-001 LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG/5ML;2.5MG/5ML SOLUTION / ORAL Approved before 1982
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N012699-001 LOMOTIL 0.025MG/5ML;2.5MG/5ML SOLUTION / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N012699-001 LOMOTIL 0.025MG/5ML;2.5MG/5ML SOLUTION / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012699-001 LOMOTIL 0.025MG/5ML;2.5MG/5ML SOLUTION / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012699-001 LOMOTIL 0.025MG/5ML;2.5MG/5ML SOLUTION / ORAL Approved before 1982 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lomotil DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Pfizer Laboratories Div Pfizer Inc f170584a-1072-4fd7-b1dc-6756703483b9 2026-02-23 Warnings, Adverse reactions Name fallback brand name: Lomotil
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 12030 SUPPL 2006-05-02