Application 216120

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROPINE SULFATE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS	0.4MG/ML (0.4MG/ML)	No	No
002	ATROPINE SULFATE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS	1MG/ML (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
A216120-001	ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26
A216120-002	ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216120-001	AP
A216120-002	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 · 60 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	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-05-26	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216120-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216120-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216120-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216120-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216120-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216120-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216120-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216120-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216120-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216120-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216120-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216120-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216120-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216120-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216120-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216120-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216120-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216120-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216120-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216120-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216120-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216120-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216120-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216120-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216120-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	AP	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A216120-001	CGT	2023-01-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216120-002	CGT	2023-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-001	CGT	2023-01-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216120-002	CGT	2023-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216120-001	CGT	2023-01-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216120-002	CGT	2023-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216120-001	CGT	2023-01-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216120-002	CGT	2023-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216120-001	CGT	2023-01-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216120-002	CGT	2023-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216120-001	CGT	2023-01-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216120-002	CGT	2023-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216120-001	CGT	2023-01-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216120-002	CGT	2023-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216120-001	CGT	2023-01-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216120-002	CGT	2023-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216120-001	CGT	2023-01-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A216120-002	CGT	2023-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216120-001	CGT	2023-01-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A216120-002	CGT	2023-01-29	`e64feba35796…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc	b753894e-81f8-4e81-b07a-c338311ded5b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3ef1a1a0-93c1-e6b6-e063-6294a90aa2b6	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	0060b971-19bd-2849-e063-6294a90afca8	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine sulfate	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	007728fc-f4cb-d519-e063-6394a90ae033	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	09d086f2-db9a-5e15-e063-6394a90abe18	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120
Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	6fee1727-52b7-4f73-ab45-ef47d6a1c5bb	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216120 application number: ANDA216120 ndc (product): 0517-1004 ndc (product): 0517-1001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-1001	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current
0517-1001	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current
0517-1001	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current
0517-1004	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current
0517-1004	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current
0517-1004	Atropine Sulfate	ATROPINE SULFATE	American Regent, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71877	ORIG	2022-08-25