Application 206289

Type: NDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROPINE SULFATE	ATROPINE SULFATE	SOLUTION/DROPS;OPHTHALMIC	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N206289-001	ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206289-001	AT1

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 · 43 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	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD	2014-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2014-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2014-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2014-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2014-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2014-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD	2014-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206289-001	ATROPINE SULFATE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2014-07-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N206289-001	AT1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206289-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206289-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206289-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206289-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206289-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206289-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206289-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206289-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206289-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206289-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206289-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206289-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206289-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206289-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206289-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206289-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206289-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206289-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N206289-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206289-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206289-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206289-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206289-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206289-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206289-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206289-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206289-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206289-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206289-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206289-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206289-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206289-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206289-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206289-001	AT1	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 2 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	NorthStar RxLLC	f750135c-e6bf-4aa7-a343-87b1204df94f	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE MONOHYDRATE	Medical Purchasing Solutions, LLC	423fc064-57cb-8308-e063-6394a90a2617	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc	b753894e-81f8-4e81-b07a-c338311ded5b	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	6acb3f07-9e32-4ad0-8336-e2f33d55b127	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Lifestar Pharma LLC	b5f78b2a-56d1-4400-9d2f-b033cc13d26e	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	a66eecf9-2d8b-4e2d-8a05-d718dcbc3542	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
ATROPINE SULFATE	ATROPINE SULFATE	Accord Healthcare, Inc.,	c82cb295-ffce-47d6-97ad-a8aa723f4e4f	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: ATROPINE SULFATE generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	3fa81939-4495-28d5-e063-6394a90a1f2d	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3ef1a1a0-93c1-e6b6-e063-6294a90aa2b6	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE INJECTION	ProPharma Distribution	3eeed115-0e17-c4b2-e063-6294a90a29b7	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate
Atropine Sulfate	ATROPINE SULFATE	ProPharma Distribution	3eef6300-9c78-82b2-e063-6294a90a5499	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine sulfate	ATROPINE SULFATE	Somerset Therapeutics, LLC	e30491ed-938e-4ef4-aa23-a2e94cbab0ed	2025-05-29	Warnings, Adverse reactions	Name fallback brand name: Atropine sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	d4839e54-b350-4643-8e6e-f0437f5349d6	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Bausch & Lomb Incorporated	aeab333c-3cdb-45c0-9e22-949624d69fbc	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	International Medication Systems, Limited	b72d0a82-6163-460f-965a-12f6da47370a	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	3f931937-7bc0-416b-e063-6294a90a28b5	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE MONOHYDRATE	Somerset Therapeutics, LLC	84ba1689-3030-48d5-9cce-70b5a24a4033	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate
Atropine Sulfate	ATROPINE SULFATE	Accord Healthcare Inc.	f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Fresenius Kabi USA, LLC	310c8a74-ea24-4357-8099-81e394b1634e	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Atropine Sulfate generic name: ATROPINE SULFATE
Atropine Sulfate	ATROPINE SULFATE	Somerset Therapeutics, LLC	a6fac578-c7bc-4b3c-a454-7889cc819118	2024-07-04	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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13985-606	Atropine	Atropine Sulfate	MWI	NDA	Current
13985-606	Atropine	Atropine Sulfate	MWI	NDA	Current
13985-606	Atropine	Atropine Sulfate	MWI	NDA	Current
13985-606	Atropine	Atropine Sulfate	MWI	NDA	Current
17478-215	Atropine	Atropine Sulfate	Akorn, Inc.	NDA	Current
17478-215	Atropine	Atropine Sulfate	Akorn	NDA	Current
17478-215	Atropine	Atropine Sulfate	Akorn	NDA	Current
17478-215	Atropine	Atropine Sulfate	Akorn, Inc.	NDA	Current
17478-215	Atropine	Atropine Sulfate	Akorn	NDA	Current
50090-3104	Atropine	Atropine Sulfate	A-S Medication Solutions	NDA	Current
50090-3104	Atropine	Atropine Sulfate	A-S Medication Solutions	NDA	Current
50090-6295	Atropine	Atropine Sulfate	A-S Medication Solutions	NDA	Current
76478-015	Atropine	Atropine Sulfate	Akorn	NDA	Current
76478-015	Atropine	Atropine Sulfate	Akorn	NDA	Current
76478-015	Atropine	Atropine Sulfate	Akorn	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83405	SUPPL	2025-09-19
83394	SUPPL	2025-09-19
71135	SUPPL	2022-05-23
70573	SUPPL	2022-03-21
44940	ORIG	2015-04-07
43512	ORIG	2015-04-07
32791	ORIG	2014-07-23
19712	ORIG	2014-07-23
51757	ORIG	1900-01-01
51756	ORIG	1900-01-01
51755	ORIG	1900-01-01