Application 204652

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCYTOSINE	FLUCYTOSINE	CAPSULE;ORAL	250MG	No	No
002	FLUCYTOSINE	FLUCYTOSINE	CAPSULE;ORAL	500MG	No	No

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

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
A204652-001	FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB		2017-07-07
A204652-002	FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB		2017-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204652-001	AB
A204652-002	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 3 · 82 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	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204652-001	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	2017-07-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204652-002	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	2017-07-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A204652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204652-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204652-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204652-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204652-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204652-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204652-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204652-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204652-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204652-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204652-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204652-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204652-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204652-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204652-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204652-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flucytosine	FLUCYTOSINE	AvPAK	bfc817db-ab65-5cd7-e053-2995a90a8ee8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204652 application number: ANDA204652 ndc (product): 50268-332 ndc (product): 50268-331
Flucytosine	FLUCYTOSINE	Major Pharmaceuticals	01d874f9-e073-4092-94ad-da361551d4bf	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204652 application number: ANDA204652 ndc (product): 0904-6834 ndc (product): 0904-6835
Flucytosine	FLUCYTOSINE	Lupin Pharmaceuticals,Inc.	5721b46a-4a9f-46c2-8804-a9bad4d5f80a	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204652 application number: ANDA204652 ndc (product): 43386-771 ndc (product): 43386-770
Flucytosine	FLUCYTOSINE	Novel Laboratories, Inc.	ee98e0a9-c125-4b5c-ba4e-ca3c9a1f2b90	2022-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204652 application number: ANDA204652 ndc (product): 40032-770 ndc (product): 40032-771

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6834	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
0904-6834	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
0904-6834	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
0904-6835	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
0904-6835	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
0904-6835	Flucytosine	Flucytosine	Major Pharmaceuticals	ANDA	Current
40032-770	Flucytosine	Flucytosine	Novel Laboratories, Inc.	ANDA	Current
40032-770	Flucytosine	Flucytosine	Novel Laboratories, Inc.	ANDA	Current
40032-771	Flucytosine	Flucytosine	Novel Laboratories, Inc.	ANDA	Current
40032-771	Flucytosine	Flucytosine	Novel Laboratories, Inc.	ANDA	Current
43386-770	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-770	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-770	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-771	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-771	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-771	Flucytosine	Flucytosine	Lupin Pharmaceuticals,Inc.	ANDA	Current
50268-331	Flucytosine	Flucytosine	AvPAK	ANDA	Current
50268-331	Flucytosine	Flucytosine	AvPAK	ANDA	Current
50268-332	Flucytosine	Flucytosine	AvPAK	ANDA	Current
50268-332	Flucytosine	Flucytosine	AvPAK	ANDA	Current
60687-352	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-352	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-352	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-352	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-352	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-363	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-363	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-363	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-363	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current
60687-363	Flucytosine	Flucytosine	American Health Packaging	ANDA	Current