Application 213090

Type: ANDA
Sponsor: HIBROW HLTHCARE

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
002	NIACIN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	750MG	No	No
003	NIACIN	NIACIN	TABLET, EXTENDED RELEASE;ORAL	1GM	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	Approval date
A213090-001	NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25
A213090-002	NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25
A213090-003	NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213090-001	AB
A213090-002	AB
A213090-003	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 · 60 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	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-002	NIACIN	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-003	NIACIN	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213090-001	NIACIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A213090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213090-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213090-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213090-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213090-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213090-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213090-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213090-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213090-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213090-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213090-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213090-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213090-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213090-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213090-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213090-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213090-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213090-001	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Niacin	NIACIN	Golden State Medical Supply, Inc.	8eff9205-84ac-e69d-e053-2995a90aad4b	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacin	NIACIN	AvPAK	dd60fe81-3d54-4a29-9502-601be89c575e	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacin	NIACIN	Amneal Pharmaceuticals LLC	6e604319-e164-4056-ab80-b78b98c519c7	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacin	NIACIN	Redmont Pharmaceuticals, LLC	f51f7e6d-b132-48d8-8bb1-54203472f0d8	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
NIACIN	NIACIN	Chartwell RX, LLC	568c3a99-b6e8-48b4-bb68-867bbcefa027	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: NIACIN generic name: NIACIN
Niacin	NIACIN	Lannett Company, Inc.	d7b66e13-00ed-48a9-a54a-8e474cc31d54	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacin	NIACIN	Amneal Pharmaceuticals LLC	7250313b-b2ef-4736-bd25-2f29c2ac0eb9	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacin	NIACIN	Macleods Pharmaceuticals Limited	52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e	2025-01-10	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
NIACIN	NIACIN	Sun Pharmaceutical Industries, Inc.	8e290f96-e8c6-47fd-863f-1c9480f28d9b	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: NIACIN generic name: NIACIN
NIACIN	NIACIN	Lupin Pharmaceuticals, Inc.	92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9	2023-10-06	Warnings, Adverse reactions	Name fallback brand name: NIACIN generic name: NIACIN
Niacin	NIACIN	Aurobindo Pharma Limited	43233a21-3f90-4c69-bbeb-f50d5f2d35ae	2023-02-14	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN
Niacor	NIACIN	Avondale Pharmaceuticals, LLC	bf287412-160b-403f-8eb4-57f29a475902	2021-12-23	Warnings, Adverse reactions	Name fallback generic name: NIACIN
Niacin	NIACIN	Emerald Therapeutics, LLC	5fceeb58-e54d-43c1-8abb-33feea69d663	2021-04-07	Warnings, Adverse reactions	Name fallback brand name: Niacin generic name: NIACIN