Application 213255

Type: ANDA
Sponsor: MYLAN

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

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
A213255-001	ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2020-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213255-001	AP1

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	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213255-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2020-08-07	`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	A213255-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213255-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213255-001	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213255-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213255-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213255-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213255-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213255-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213255-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213255-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213255-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213255-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213255-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213255-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213255-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213255-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213255-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213255-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213255-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213255-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213255-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213255-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213255-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213255-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213255-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213255-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213255-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213255-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213255-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213255-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213255-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213255-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213255-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213255-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213255-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213255-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213255-001	AP1	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Mylan Institutional LLC	1d456d07-fca2-4d43-92c0-f3b3c8b54420	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213255 application number: ANDA213255 ndc (product): 67457-940

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-940	Acetaminophen	Acetaminophen	Mylan Institutional LLC	ANDA	Current
67457-940	Acetaminophen	Acetaminophen	Mylan Institutional LLC	ANDA	Current
67457-940	Acetaminophen	Acetaminophen	Mylan Institutional LLC	ANDA	Current