Home Applications 214652 Application 214652
Type NDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ATROPINE SULFATE ATROPINE SULFATE SOLUTION; INJECTION 0.4MG/ML No No 002 ATROPINE SULFATE ATROPINE SULFATE SOLUTION; INJECTION 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214652-001 ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 N214652-002 ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 76 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 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD 2020-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD 2020-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16729-525 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare Inc. NDA Current 16729-525 ATROPINE SULFATE ATROPINE SULFATE Accord Healthcare Inc. NDA Current 16729-526 Atropine Sulfate ATROPINE SULFATE Accord Healthcare Inc. NDA Current 16729-526 Atropine Sulfate ATROPINE SULFATE Accord Healthcare Inc. NDA Current 71872-7245 Atropine Sulfate ATROPINE SULFATE Medical Purchasing Solutions, LLC NDA Current 71872-7245 Atropine Sulfate ATROPINE SULFATE Medical Purchasing Solutions, LLC NDA Current 71872-7246 ATROPINE SULFATE ATROPINE SULFATE Medical Purchasing Solutions, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84925 SUPPL 2026-02-05 84924 SUPPL 2026-02-05 81288 SUPPL 2025-02-19 66245 ORIG 2021-02-17 64767 ORIG 2020-09-30 64765 ORIG 2020-09-30