Application 090860

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIACIN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No

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

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
A090860-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2014-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090860-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090860-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-03-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090860-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090860-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090860-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090860-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090860-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090860-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090860-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090860-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090860-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090860-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090860-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090860-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090860-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090860-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090860-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090860-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090860-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090860-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090860-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090860-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090860-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090860-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090860-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090860-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090860-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090860-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090860-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090860-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090860-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090860-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090860-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090860-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090860-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090860-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090860-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090860-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090860-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090860-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090860-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090860-001	AB	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	2023-10-06	Warnings, Adverse reactions	Exact identifier ndc (product): 68180-221

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-116	NIACIN	NIACIN	Golden State Medical Supply Inc.	ANDA	Current
51407-116	NIACIN	NIACIN	Golden State Medical Supply, Inc.	ANDA	Current
51407-116	NIACIN	NIACIN	Golden State Medical Supply	ANDA	Current
57297-221	NIACIN	NIACIN	LUPIN LIMITED	ANDA	Current
63629-7193	NIACIN	NIACIN	Bryant Ranch Prepack	ANDA	Current
63629-7193	NIACIN	NIACIN	Bryant Ranch Prepack	ANDA	Current
68084-756	NIACIN	NIACIN	American Health Packaging	ANDA	Current
68084-756	NIACIN	NIACIN	American Health Packaging	ANDA	Current
68084-756	NIACIN	NIACIN	American Health Packaging	ANDA	Current
68084-756	NIACIN	NIACIN	American Health Packaging	ANDA	Current
68180-221	NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-221	NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-221	NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-221	NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	ANDA	Current