Application 212461

Type: ANDA
Sponsor: INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROPINE SULFATE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS	1MG/10ML (0.1MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212461-001	ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP		2020-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212461-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AA	2020-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AA	2020-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AA	2020-10-05	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212461-001	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-10-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212461-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212461-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212461-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212461-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212461-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212461-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212461-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212461-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212461-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212461-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212461-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212461-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212461-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212461-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212461-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212461-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212461-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212461-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212461-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212461-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212461-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212461-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212461-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212461-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212461-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212461-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212461-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212461-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212461-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212461-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212461-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212461-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212461-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212461-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212461-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212461-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212461-001	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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atropine Sulfate	ATROPINE SULFATE	REMEDYREPACK INC.	46ba6000-b842-449a-8dd4-7bb9dc7a74c5	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461 ndc (product): 70518-3120
Atropine Sulfate	ATROPINE SULFATE	A-S Medication Solutions	739f384f-1a69-4953-93a0-aa6a76de0ecc	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461 ndc (product): 50090-5924
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3d5c747f-3bf7-2597-e063-6394a90a828c	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461
Atropine Sulfate	ATROPINE SULFATE	International Medication Systems, Limited	b72d0a82-6163-460f-965a-12f6da47370a	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461 ndc (product): 76329-3340
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c0d0ca2a-4267-41b7-e053-2a95a90a4726	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461 ndc (product): 51662-1527
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	c434062a-cd44-e684-e053-2995a90a91c3	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212461 application number: ANDA212461 ndc (product): 71872-7252

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
50090-5924	Atropine Sulfate	Atropine Sulfate	A-S Medication Solutions	ANDA	Current
51662-1527	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
70518-3120	Atropine Sulfate	Atropine Sulfate	REMEDYREPACK INC.	ANDA	Current
71872-7252	Atropine Sulfate	Atropine Sulfate	Medical Purchasing Solutions, LLC	ANDA	Current
76329-3340	Atropine Sulfate	Atropine Sulfate	International Medication Systems, Limited	ANDA	Current
76329-3340	Atropine Sulfate	Atropine Sulfate	International Medication Systems, Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65507	ORIG	2020-12-07