Application 215767

Type: ANDA
Sponsor: ANNORA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	20MG	No	No
002	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	40MG	No	No

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

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
A215767-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2021-11-04
A215767-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215767-001	AB
A215767-002	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 2 · 68 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
2026-08-18 06:07:40	2026-07	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215767-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215767-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215767-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215767-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215767-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215767-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215767-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215767-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215767-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215767-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215767-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215767-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215767-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215767-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215767-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215767-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215767-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215767-002	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Redpharm Drug	55730918-d9e8-eaad-e063-6394a90aeda2	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	31cdc900-fe17-2d5f-e063-6294a90a0fda	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals, Inc.	b1edf3c5-e42c-471b-8771-6c93094822de	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	002875d2-8c30-2d2e-e063-6294a90ae01e	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	2f5ec69d-926c-47a2-be47-8fef2e0ff207	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	e034546b-28cb-41aa-9441-655cdb966554	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals, Inc.	2cdd1a75-5d68-7f9d-e063-6294a90aeee3	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Advanced Rx Pharmacy of Tennessee, LLC	fa18ed52-f038-02dd-e053-6394a90ac946	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Acid Reducer	FAMOTIDINE	Allegiant Health	5c6c6665-cb0a-41d1-af28-85b4f061bd1b	2024-10-30	Warnings	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	66878006-8913-4c91-8038-901142cf520d	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	0abfc8e6-7fdf-4828-89f4-2202002f8489	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	75a334ee-48b9-47e7-8225-6e595bed8a74	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	99de67a5-a566-46c9-bc80-dc6fc03be11f	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Camber Pharmaceuticals, Inc.	902b5d4b-1707-4312-9f46-ef5ab86b00f0	2021-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767 ndc (product): 31722-017 ndc (product): 31722-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-017	Famotidine	Famotidine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-018	Famotidine	Famotidine	Camber Pharmaceuticals, Inc.	ANDA	Current