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 44.

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.

Application-product, TE code table
Application-product	TE code
N214652-001	AP
N214652-002	AP

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 · 80 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
2026-10-15 13:18:30	2026-09	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214652-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214652-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2020-09-29	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N214652-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214652-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214652-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214652-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214652-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214652-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214652-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214652-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214652-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214652-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214652-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214652-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214652-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214652-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214652-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214652-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214652-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214652-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214652-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214652-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214652-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214652-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214652-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214652-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214652-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214652-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214652-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214652-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214652-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214652-002	AP	1	`ea1830bbd6c7…`

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atropine Sulfate	ATROPINE SULFATE MONOHYDRATE	Somerset Therapeutics, LLC	bfdb85b2-86d0-4f32-a8fa-272af48a191c	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co. LLC, DBA Health First	74106ef7-83bf-47ba-e053-2991aa0aaec1	2024-03-08	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	0060b971-19bd-2849-e063-6294a90afca8	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fd624a-9abd-dfea-e053-2a95a90a8e9d	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co., LLC, DBA Health First	73de9878-a08a-4966-e053-2a91aa0ab0f6	2024-01-25	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine sulfate	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	007728fc-f4cb-d519-e063-6394a90ae033	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: Atropine sulfate generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c0d0ca2a-4267-41b7-e053-2a95a90a4726	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine	ATROPINE SULFATE	A-S Medication Solutions	1b2d030e-c0ec-484b-a228-76011702cdd0	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	0aab13de-04bf-2a14-e063-6294a90aae11	2023-11-15	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	09d086f2-db9a-5e15-e063-6394a90abe18	2023-11-10	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	6bb51b79-ae86-aebf-e053-2991aa0a8d33	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	c434062a-cd44-e684-e053-2995a90a91c3	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	fa1c953b-723b-1abe-e053-6394a90a967f	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	4c15d3cc-7888-4c82-b3f8-a5d93c5523df	2023-01-26	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	66710a22-2eaa-6dbd-e053-2a91aa0a900d	2022-10-13	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Isopto Atropine	ATROPINE SULFATE	Alcon Laboratories, Inc.	20491566-e6eb-8d4a-3083-77ea429f7bc4	2022-10-07	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	6fee1727-52b7-4f73-ab45-ef47d6a1c5bb	2021-09-01	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	77935b57-fcf6-c88a-e053-2a91aa0a0a80	2020-09-04	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Bausch & Lomb Incorporated	c0a56d60-0914-42b1-af59-c56afe93d18c	2020-04-02	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE

Reported adverse events (FAERS/openFDA)#

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

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