Application 021146

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROPINE SULFATE ANSYR PLASTIC SYRINGE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ATROPINE SULFATE ANSYR PLASTIC SYRINGE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL	0.25MG/5ML (0.05MG/ML)	Yes	Yes
003	ATROPINE SULFATE ANSYR PLASTIC SYRINGE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL	1MG/10ML (0.1MG/ML)	Yes	Yes
004	ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS	0.5MG/5ML (0.1MG/ML)	Yes	Yes
005	ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE	ATROPINE SULFATE	SOLUTION;INTRAVENOUS	1MG/10ML (0.1MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021146-001	ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09
N021146-002	ATROPINE SULFATE	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09
N021146-003	ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021146-001	AP
N021146-002	AP
N021146-003	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 4 · 143 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	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-002	ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-003	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-001	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	AP	RLD, RS	2001-07-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 106 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	N021146-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021146-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021146-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021146-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021146-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021146-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021146-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021146-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021146-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021146-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021146-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021146-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021146-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021146-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021146-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021146-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021146-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021146-001	AP	1	`1e350fbaab3a…`

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	HF Acquisition Co LLC, DBA HealthFirst	768dc21a-b7d9-144c-e053-2991aa0af889	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (product): 51662-1289
Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	ad8916e7-206e-409e-2582-30d072845dd4	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (product): 0409-4910 ndc (product): 0409-9630 ndc (product): 0409-1630 ndc (product): 0409-4911
Atropine Sulfate	ATROPINE SULFATE	Henry Schein, Inc.	d4839e54-b350-4643-8e6e-f0437f5349d6	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (product): 0404-9823
Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	66710a22-2eaa-6dbd-e053-2a91aa0a900d	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (product): 71872-7002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9823	Atropine Sulfate	Atropine Sulfate	Henry Schein, Inc.	NDA	Current
0404-9823	Atropine Sulfate	Atropine Sulfate	Henry Schein, Inc.	NDA	Current
0404-9823	Atropine Sulfate	Atropine Sulfate	Henry Schein, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-1630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	ATROPINE SULFATE	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4910	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	ATROPINE SULFATE	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-4911	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
0409-9630	Atropine Sulfate	ATROPINE SULFATE	Hospira, Inc.	NDA	Current
50090-2181	ATROPINE SULFATE	ATROPINE SULFATE	A-S Medication Solutions	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1289	ATROPINE SULFATE	ATROPINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
52584-630	Atropine Sulfate	Atropine Sulfate	General Injectables & Vaccines, Inc.	NDA	Current
71872-7002	Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7002	Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7002	Atropine Sulfate	ATROPINE SULFATE	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83010	SUPPL	2025-08-01
83007	SUPPL	2025-07-31
65970	SUPPL	2021-01-25
65965	SUPPL	2021-01-25
63700	SUPPL	2020-06-25
63697	SUPPL	2020-06-25
57337	SUPPL	2019-01-23
50259	SUPPL	2017-11-02
47069	SUPPL	2017-01-31
14495	SUPPL	2015-11-04
4459	SUPPL	2015-11-04
21476	ORIG	2004-05-27
26899	ORIG	2001-07-09
14494	ORIG	2001-07-09