Application 211890

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN AND FAMOTIDINE	IBUPROFEN; FAMOTIDINE	TABLET;ORAL	800MG; 26.6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211890-001	IBUPROFEN AND FAMOTIDINE	FAMOTIDINE; IBUPROFEN	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211890-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB		2021-08-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211890-001	IBUPROFEN AND FAMOTIDINE	26.6MG;800MG	TABLET / ORAL	AB	RS	2021-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211890-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211890-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211890-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211890-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211890-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211890-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211890-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211890-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211890-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211890-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211890-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211890-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211890-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211890-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211890-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211890-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211890-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211890-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211890-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211890-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211890-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211890-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211890-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211890-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211890-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211890-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211890-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211890-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211890-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211890-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211890-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211890-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211890-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211890-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Doc Rx	9f5de6af-e555-4efd-a3ed-b72c34c051b6	2026-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890 ndc (product): 69306-266
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Ascend Laboratories, LLC	4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890 ndc (product): 67877-626
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	PHOENIX RX LLC	4ee3e849-2197-8883-e063-6394a90a1748	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	REMEDYREPACK INC.	b969bb72-66de-47ce-9d77-64d029e1a5c9	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen Famotidine	IBUPROFEN FAMOTIDINE	Direct_Rx	3f16596d-dd5a-7985-e063-6294a90a6f9d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Preferred Pharmaceuticals Inc.	e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	PHOENIX RX LLC	397f1f23-10c2-569e-e063-6394a90a7164	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Asclemed USA, Inc.	41123df3-97ac-4c4f-9a89-f76ec03898bb	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Bryant Ranch Prepack	ee69d3cb-dc95-410c-a7c8-6623073a923d	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890 ndc (product): 63629-8891
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Advanced Rx of Tennessee, LLC	1d625438-34dc-fbba-e063-6294a90afd2f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211890 application number: ANDA211890

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8891	Ibuprofen and famotidine	Ibuprofen and famotidine	Bryant Ranch Prepack	ANDA	Current
63629-8891	Ibuprofen and famotidine	Ibuprofen and famotidine	Bryant Ranch Prepack	ANDA	Current
67877-626	Ibuprofen and famotidine	Ibuprofen and famotidine	Ascend Laboratories, LLC	ANDA	Current
67877-626	Ibuprofen and famotidine	Ibuprofen and famotidine	Ascend Laboratories, LLC	ANDA	Current
69306-266	Ibuprofen and famotidine	Ibuprofen and famotidine	Doc Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68522	ORIG	2021-09-02