Application 213561

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROPINE SULFATE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	8MG/20ML (0.4MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213561-001	ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP		2021-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213561-001	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
2026-08-18 06:07:40	2026-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213561-001	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	AP	2021-12-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213561-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213561-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213561-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213561-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213561-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213561-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213561-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213561-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213561-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213561-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213561-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213561-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213561-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213561-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213561-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213561-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213561-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213561-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213561-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213561-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213561-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213561-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213561-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213561-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213561-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213561-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213561-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213561-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213561-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213561-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213561-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213561-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213561-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213561-001	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 · 4 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	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561
ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fd624a-9abd-dfea-e053-2a95a90a8e9d	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561 ndc (product): 51662-1619
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	0aab13de-04bf-2a14-e063-6294a90aae11	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561
Atropine Sulfate	ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	4c15d3cc-7888-4c82-b3f8-a5d93c5523df	2023-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213561 application number: ANDA213561 ndc (product): 0641-6251

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9990	ATROPINE SULFATE	atropine sulfate injection	Henry Schein, Inc.	ANDA	Current
0641-6251	Atropine Sulfate	Atropine Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1619	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1619	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current