Application 040541

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTRADECOL	SODIUM TETRADECYL SULFATE	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	No	Yes
002	SOTRADECOL	SODIUM TETRADECYL SULFATE	INJECTABLE;INJECTION	60MG/2ML (30MG/ML)	No	Yes

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

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
A040541-001	SOTRADECOL	SODIUM TETRADECYL SULFATE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12
A040541-002	SOTRADECOL	SODIUM TETRADECYL SULFATE	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040541-002	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 3 · 84 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	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`bb7c543d1eb4…`

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	A040541-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040541-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040541-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040541-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040541-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040541-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040541-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040541-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040541-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040541-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040541-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040541-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040541-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040541-002	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040541-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040541-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040541-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040541-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040541-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040541-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040541-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040541-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040541-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040541-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040541-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040541-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040541-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040541-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM TETRADECYL SULFATE	SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c76f4b3b-9f93-349f-e053-2995a90a2d57	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541 ndc (product): 51662-1562
Sotradecol	TETRADECYL HYDROGEN SULFATE (ESTER)	Mylan Institutional LLC	f1756c28-dcd2-4b49-be62-07ca20682018	2021-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541 ndc (product): 67457-163 ndc (product): 67457-162
(SOTRADECOL) SODIUM TETRADECYL SULFATE	(SOTRADECOL) SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c59db022-bda8-1732-e053-2a95a90a24f8	2021-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541 ndc (product): 51662-1563

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4525	Sotradecol	tetradecyl hydrogen sulfate (ester)	A-S Medication Solutions	ANDA	Current
50090-4529	Sotradecol	tetradecyl hydrogen sulfate (ester)	A-S Medication Solutions	ANDA	Current
51662-1562	SODIUM TETRADECYL SULFATE	SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1563	(SOTRADECOL) SODIUM TETRADECYL SULFATE	(SOTRADECOL) SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
67457-162	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current
67457-162	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current
67457-162	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current
67457-163	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current
67457-163	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current
67457-163	Sotradecol	tetradecyl hydrogen sulfate (ester)	Mylan Institutional LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7670	ORIG	2004-11-16