Application 214554

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	FOR SOLUTION;ORAL	EQ 3GM BASE/PACKET	No	No

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

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
A214554-001	FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA		2021-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214554-001	AA

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
2026-08-18 06:07:40	2026-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a50c72e98297…`

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	A214554-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214554-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214554-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214554-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214554-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214554-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214554-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214554-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214554-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214554-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214554-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214554-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214554-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214554-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214554-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214554-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214554-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214554-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214554-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214554-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214554-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214554-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214554-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214554-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214554-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214554-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214554-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214554-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214554-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214554-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214554-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214554-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214554-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214554-001	AA	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
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	Ascend Laboratories, LLC	48e352bc-52ea-4778-905a-60ef38a5c18a	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554 ndc (product): 67877-749
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	Kesin Pharma Corporation	3fa61bd4-fc55-0987-e063-6394a90abce2	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	A-S Medication Solutions	6b9167a9-80e9-44e1-a609-c3eb78960acf	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554 ndc (product): 50090-6130

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
50090-6130	Fosfomycin Tromethamine	Fosfomycin Tromethamine	A-S Medication Solutions	ANDA	Current
63629-9470	Fosfomycin Tromethamine	Fosfomycin Tromethamine	Bryant Ranch Prepack	ANDA	Current
67877-749	Fosfomycin Tromethamine	Fosfomycin Tromethamine	Ascend Laboratories, LLC	ANDA	Current
67877-749	Fosfomycin Tromethamine	Fosfomycin Tromethamine	Ascend Laboratories, LLC	ANDA	Current