Application 016620

Type: NDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	50MG	Yes	No
002	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	100MG	Yes	Yes
003	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	25MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N016620-001	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	RLD, Approved before 1982
N016620-002	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	RLD, Approved before 1982
N016620-003	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	RLD, Approved before 1982

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016620-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantion Macrocrystals	NITROFURANTION MACROCRYSTALS	Proficient Rx LP	3b53f9bf-866a-4cb1-9180-7b13896e26ba	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016620 application number: NDA016620 ndc (product): 63187-245
Nitrofurantion Macrocrystals	NITROFURANTION MACROCRYSTALS	Proficient Rx LP	29b72c21-ab85-41de-b025-f139e6e13ccc	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016620 application number: NDA016620 ndc (product): 71205-023

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7136	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	NDA	Current
12634-415	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Apotheca Inc.	NDA	Current
33261-226	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Aidarex Pharmaceuticals LLC	NDA	Current
43063-400	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	PD-Rx Pharmaceuticals, In	NDA	Current
43063-400	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-400	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-400	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-400	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-400	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-400	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-675	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-675	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-675	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-675	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	PD-Rx Pharmaceuticals, Inc.	NDA	Current
47781-306	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-306	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-306	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-306	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-306	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-307	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-307	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-307	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-307	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-307	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-308	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-308	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-308	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-308	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
47781-308	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Alvogen Inc.	NDA	Current
50090-0314	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	A-S Medication Solutions	NDA	Current
50436-0308	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Unit Dose Services	NDA	Current
52427-286	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-286	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-286	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-286	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-286	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-287	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-287	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-287	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-287	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-287	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-288	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-288	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-288	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
52427-288	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma LLC	NDA	Current
52427-288	Macrodantin	Nitrofurantoin macrocrystals	Almatica Pharma Inc.	NDA	Current
55700-295	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-295	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-295	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Lake Erie Medical DBA Qua	NDA	Current
55700-295	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-388	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
61919-458	NITROFURANTOIN MACROCRYSTALS	nitrofurantoin	DIRECT RX	NDA	Current
61919-458	NITROFURANTOIN MACROCRYSTALS	nitrofurantoin	DIRECT RX	NDA	Current
61919-458	NITROFURANTOIN MACROCRYSTALS	nitrofurantoin	DIRECT RX	NDA	Current
63187-245	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Proficient Rx LP	NDA	Current
63187-245	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Proficient Rx LP	NDA	Current
63187-245	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Proficient Rx LP	NDA	Current
63629-6653	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Bryant Ranch Prepack	NDA	Current
66267-156	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	NuCare Pharmaceuticals, Inc.	NDA	Current
68001-002	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	BluePoint Laboratories	NDA	Current
68001-003	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	BluePoint Laboratories	NDA	Current
68084-077	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	American Health Packaging	NDA	Current
68084-077	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	American Health Packaging	NDA	Current
68084-078	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	American Health Packaging	NDA	Current
68084-078	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	American Health Packaging	NDA	Current
68788-6874	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7806	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7806	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7806	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Preferred Pharmaceuticals Inc.	NDA	Current
70518-0103	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	REMEDYREPACK INC.	NDA	Current
70518-0103	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	REMEDYREPACK INC.	NDA	Current
71205-023	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Proficient Rx LP	NDA	Current
71205-023	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Proficient Rx LP	NDA	Current
71335-0500	Nitrofurantion Macrocrystals	nitrofurantoin macrocrystals	Bryant Ranch Prepack	NDA	Current
71335-0500	Nitrofurantion Macrocrystals	Nitrofurantion Macrocrystals	Bryant Ranch Prepack	NDA	Current
71335-2074	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Bryant Ranch Prepack	NDA	Current
76413-144	Nitrofurantoin	Nitrofurantion Macrocrystals	Central Texas Community Health Centers	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68427	SUPPL	2021-08-20
65960	SUPPL	2021-01-22
13012	SUPPL	2013-09-10
10903	SUPPL	2013-09-09
13011	SUPPL	2011-06-09
33186	SUPPL	2009-03-17
467	SUPPL	2009-03-06
40719	SUPPL	2008-08-11
20060	SUPPL	2008-08-11
40720	SUPPL	2008-08-01
20061	SUPPL	2008-07-31
40718	SUPPL	2008-02-19
40717	SUPPL	2008-02-19
40716	SUPPL	2008-02-19
20059	SUPPL	2008-02-19
20058	SUPPL	2008-02-19
13010	SUPPL	2007-09-25
33185	SUPPL	2007-09-19
40714	SUPPL	2007-07-09
40713	SUPPL	2007-07-09
20056	SUPPL	2007-07-09
20055	SUPPL	2007-07-09
20054	SUPPL	2007-07-09
20057	SUPPL	2007-02-20
40715	SUPPL	2006-05-10
466	SUPPL	2004-04-07
33184	SUPPL	2004-04-05
13009	SUPPL	2003-02-04