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 43.

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 · 78 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
2026-09-14 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214652-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214652-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214652-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214652-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214652-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214652-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214652-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N214652-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214652-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N214652-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214652-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214652-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214652-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N214652-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214652-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N214652-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214652-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214652-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214652-002	AP	1	`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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	8663ff94-8bea-4061-9fd5-3ab2e85e862e	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	532aa441-92ec-42d6-862a-639f8cfe9951	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine	ATROPINE SULFATE	Gland Pharma Limited	a116af5c-ba4c-408c-9a02-4bc33772aa8d	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	0f5b0961-efe7-42c3-898e-2f7fc7fc90b1	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	768dc21a-b7d9-144c-e053-2991aa0af889	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	ad8916e7-206e-409e-2582-30d072845dd4	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine sulfate	ATROPINE SULFATE	Edenbridge Pharmaceuticals LLC.	b39f5876-5d6f-4a8f-bd24-bd4be24ff568	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Atropine sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	46ba6000-b842-449a-8dd4-7bb9dc7a74c5	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
atropine sulfate	ATROPINE SULFATE	Alcon Laboratories, Inc.	c8093125-ed1a-4eb6-9c81-52c5c7376481	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: atropine sulfate generic name: ATROPINE SULFATE
Atropine	ATROPINE SULFATE	Apotex Corp.	127a7e32-a150-01d6-a66a-b7708d85809f	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	A-S Medication Solutions	739f384f-1a69-4953-93a0-aa6a76de0ecc	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
ATROPINE	ATROPINE SULFATE	A-S Medication Solutions	b4736dbc-b7c8-4b33-b7a8-a47c5654a127	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Bausch & Lomb Americas Inc.	e294ce2b-6bb5-4f84-8a6d-ce2402ed926d	2026-02-07	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine	ATROPINE SULFATE	Redpharm Drug	46e98d0b-3a04-7feb-e063-6394a90ac75e	2025-12-27	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Redpharm Drug	301ea0f4-a1dc-ad4f-e063-6294a90acc1c	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE INJECTION	Medefil, Inc.	fbfdf718-befe-ad22-e053-6294a90a3715	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	38404931-980b-0019-e063-6394a90a933f	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3d5c747f-3bf7-2597-e063-6394a90a828c	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine	ATROPINE SULFATE	Amneal Pharmaceuticals NY LLC	f8718be5-8fa4-4c36-a4fd-fac7c3953f5a	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: ATROPINE SULFATE
atropine sulfate	ATROPINE SULFATE	Amneal Pharmaceuticals LLC	80a31286-a741-4440-b200-290c08925d06	2025-12-01	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