Application 216629

Type: ANDA
Sponsor: GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	20MG	No	No
002	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	40MG	No	No
003	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216629-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17
A216629-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17
A216629-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216629-001	AB
A216629-002	AB
A216629-003	AB

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 · 75 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
2026-02-19 14:30 UTC	2026-02	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216629-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216629-001	AB	1	`8072bd15b7f6…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	St. Mary's Medical Park Pharmacy	febeaf8c-0f4b-cc40-e053-6394a90a873e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Redpharm Drug	37457273-38a1-f938-e063-6294a90a50ab	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	dba00759-87b4-4ecf-998e-ba03ed3d2f1a	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals Inc.	adda78ee-0cf5-4613-a748-5d6571afe354	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	8f56d6f6-a5ea-4171-9e24-d2fdb11a65f8	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	13ba97a7-598a-76a4-e063-6294a90a45c5	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Redpharm Drug	3745be12-ea1d-f450-e063-6294a90a148c	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	54a33042-a163-4f93-96cc-fbd93030e014	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	6864b3f6-c5ad-4588-ad04-5260258c6d8c	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals, Inc.	20eecc36-dfb7-0060-e063-6394a90a9d0b	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	6194face-c26c-46ed-bde7-1e29bfeabd88	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	53c3f50f-57c6-441b-afea-ec43d7943d1a	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Prefferred Pharmaceuticals Inc.	ede9846b-b4c5-4be2-9188-fd65e66cd893	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Rising Pharma Holdings, Inc.	6101b9b4-f3ef-438e-a857-b4ea55ffc679	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629 ndc (product): 64980-562 ndc (product): 64980-563 ndc (product): 64980-564
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	0b3d986c-eecc-adbe-e063-6294a90a0fb2	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	6c2ee3a4-afea-4e1f-84e6-def0221ad437	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-562	Furosemide	Furosemide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-563	Furosemide	Furosemide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-564	Furosemide	Furosemide	Rising Pharmaceuticals, Inc.	ANDA	Current
69844-051	furosemide	furosemide	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-052	furosemide	furosemide	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-053	furosemide	furosemide	Graviti Pharmaceuticals Private Limited	ANDA	Current