Application 216814

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN AND FAMOTIDINE	FAMOTIDINE; IBUPROFEN	TABLET;ORAL	26.6MG;800MG	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
A216814-001	IBUPROFEN AND FAMOTIDINE	FAMOTIDINE; IBUPROFEN	26.6MG;800MG	TABLET / ORAL	AB		2023-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216814-001	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.

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	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216814-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	2023-03-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216814-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216814-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216814-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216814-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216814-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216814-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216814-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216814-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216814-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216814-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216814-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216814-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216814-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216814-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216814-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216814-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216814-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216814-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216814-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216814-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216814-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216814-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216814-001	AB	1	`a50c72e98297…`

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
IBUPROFEN AND FAMOTIDINE	IBUPROFEN AND FAMOTIDINE	PHOENIX RX LLC	3ff33400-30e8-87fa-e063-6394a90a7f5c	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216814 application number: ANDA216814
IBUPROFEN AND FAMOTIDINE	IBUPROFEN AND FAMOTIDINE	Camber Pharmaceuticals, Inc.	7dc158a2-fdfa-4a5f-8c28-0ce5650991db	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216814 application number: ANDA216814
IBUPROFEN AND FAMOTIDINE	IBUPROFEN AND FAMOTIDINE	Advanced Rx Pharmacy of Tennessee, LLC	16c8b0db-37d0-99d9-e063-6394a90ac31b	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216814 application number: ANDA216814
IBUPROFEN AND FAMOTIDINE	IBUPROFEN AND FAMOTIDINE	Ascent Pharmaceuticals, Inc.	03733e49-7db4-4d98-b363-d0d23686ec72	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216814 application number: ANDA216814