Home Applications 212868 Application 212868
Type ANDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.25MG/5ML (0.5MG/ML) No No 002 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) No No 003 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212868-001 ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 A212868-002 ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 A212868-003 ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 1 of 3 · 102 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 2026-08-18 06:07:40 2026-07 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16729-483 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-483 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-483 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-483 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-483 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-484 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-484 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-484 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-484 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current 16729-484 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare, Inc., ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 68378 ORIG 2021-08-16