Application 208516

Type: ANDA
Sponsor: SUNNY PHARMTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	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
A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2018-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208516-001	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 · 41 observed 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	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A208516-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208516-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208516-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208516-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208516-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208516-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208516-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208516-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208516-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208516-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208516-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208516-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208516-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208516-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208516-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208516-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208516-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208516-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208516-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208516-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208516-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208516-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208516-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208516-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208516-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208516-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208516-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208516-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208516-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208516-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208516-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208516-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208516-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208516-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208516-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208516-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208516-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208516-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208516-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208516-001	AB	1	`cb3db0bc1861…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin	NITROFURANTOIN	St. Mary's Medical Park Pharmacy	09944470-807d-ad37-e063-6394a90a7bfe	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	1c5db054-58af-4932-8fad-c3883b13f987	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	d88348a0-6ab4-4490-9325-1f14a541b0a5	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	37606c6f-0d85-4314-94ae-f7732c7bc8d5	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Preferred Pharmaceuticals Inc.	729f6bbb-ab64-4b65-979a-4ad7605c5947	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 68788-8258
Nitrofurantoin	NITROFURANTOIN	Redpharm Drug, Inc.	f4c2c01d-bef7-3e5d-e053-2995a90ae0d8	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	56e07ad3-7224-4aaf-9a68-0d48d4abfec8	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin Monohydrate/Macrocrystal	NITROFURANTOIN MONOHYDRATE/MACROCRYSTAL	Direct_Rx	ee13cf2a-cde0-8ab8-e053-2a95a90a9dda	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 72189-395
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	bebbe5d6-f6ec-4191-bad3-b6e933da0688	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 63629-2464
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	75dab97e-59b4-447c-a8c9-b4d5a970098f	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	b807bd48-71ab-4578-b1d7-4d3260bf6c75	2023-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Trigen Laboratories, LLC	39ffb8c6-4dd8-4436-b857-7306c15f662a	2023-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 13811-719
Nitrofurantoin	NITROFURANTOIN	Proficient Rx LP	34d3c103-27b8-454b-9f38-c33157c3b6fc	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 71205-852

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-719	Nitrofurantoin	Nitrofurantoin	Trigen Laboratories, LLC	ANDA	Current
13811-719	Nitrofurantoin	Nitrofurantoin	Trigen Laboratories, LLC	ANDA	Current
13811-719	Nitrofurantoin	Nitrofurantoin	Trigen Laboratories, LLC	ANDA	Current
63629-2464	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-2464	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-2464	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-2464	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-2464	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-9191	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
63629-9191	Nitrofurantoin	Nitrofurantoin	Bryant Ranch Prepack	ANDA	Current
68001-423	Nitrofurantoin	Nitrofurantoin	BluePoint Laboratories	ANDA	Current
68788-8258	Nitrofurantoin	Nitrofurantoin	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-852	Nitrofurantoin	Nitrofurantoin	Proficient Rx LP	ANDA	Current
72189-395	Macrobid	Nitrofurantoin Mono/Macro	Direct_Rx	ANDA	Current