Application 214331

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	No	No
002	ACETAMINOPHEN	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	650MG/65ML (10MG/ML)	No	Yes

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

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
A214331-001	ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17
A214331-002	ACETAMINOPHEN	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214331-001	AP1

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A214331-002	PC	2026-01-07

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 · 41 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	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214331-002	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214331-002	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214331-002	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214331-002	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214331-002	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	2025-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-09-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214331-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2021-09-17	`a50c72e98297…`

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	A214331-001	AP1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214331-001	AP1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214331-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214331-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214331-001	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214331-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214331-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214331-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214331-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214331-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214331-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214331-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214331-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214331-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214331-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214331-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214331-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214331-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214331-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214331-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214331-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214331-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214331-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214331-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214331-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214331-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214331-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214331-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214331-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214331-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214331-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214331-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214331-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214331-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214331-001	AP1	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	A214331-002	PC	2026-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214331-002	PC	2026-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214331-002	PC	2026-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214331-002	PC	2026-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214331-002	PC	2026-01-07	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214331-002	PC	2026-01-07	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Baxter Healthcare Corporation	0f67c1bd-915b-4681-88dd-22f5154a80b3	2024-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214331 application number: ANDA214331 ndc (product): 36000-306

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
36000-306	Acetaminophen	Acetaminophen	Baxter Healthcare Corporation	ANDA	Current
36000-306	Acetaminophen	Acetaminophen	Baxter Healthcare Corporation	ANDA	Current
36000-306	Acetaminophen	Acetaminophen	Baxter Healthcare Corporation	ANDA	Current
36000-306	Acetaminophen	Acetaminophen	Baxter Healthcare Corporation	ANDA	Current