Application 075684

Type: ANDA
Sponsor: ATHENEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075684-001	FAMOTIDINE	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP		2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075684-001	AP

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 · 43 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
2026-09-14 22:38:34	2026-08	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075684-001	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075684-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075684-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075684-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075684-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075684-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075684-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075684-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075684-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075684-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075684-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075684-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075684-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075684-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075684-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075684-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075684-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075684-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075684-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075684-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075684-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075684-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075684-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075684-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075684-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075684-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075684-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075684-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075684-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075684-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075684-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075684-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075684-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075684-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075684-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075684-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075684-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075684-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075684-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075684-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075684-001	AP	1	`f41ea6bd6efb…`

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 2 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Family Dollar Stores, LLC	4dc7c2c4-83c7-608d-e063-6294a90a90eb	2026-06-23	Warnings	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Unit Dose Solutions, Inc.	54d93bf1-8f9a-981b-e063-6394a90a0fde	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	TWIN MED LLC	795afb99-a3f4-4ffc-a905-2f84f3d86e4c	2026-06-16	Warnings	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	TWIN MED LLC	6d97c60e-e39d-4541-ab49-d0fe3b3fa840	2026-06-16	Warnings	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Safecor Health, LLC	1b5cb132-d28f-4fbe-91f5-dc04f9a551d1	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	e59a2c97-19c7-485c-bb1b-272ddb9ae053	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	32fd4101-15cb-411e-8b9d-270ec0592c6e	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	31cdc900-fe17-2d5f-e063-6294a90a0fda	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sagent Pharmaceuticals	9710995d-b518-40ce-bc2b-8b5dcf002c31	2026-06-06	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
acid relief	FAMOTIDINE	Rite Aid Corporation	8c6d5419-088b-4b3e-80b8-2a0d06926ff1	2026-06-03	Warnings	Name fallback generic name: FAMOTIDINE
ACID REDUCER	FAMOTIDINE	HyVee Inc	381db08e-5756-4255-8202-1d8e6a1cf038	2026-06-03	Warnings	Name fallback generic name: FAMOTIDINE
acid relief	FAMOTIDINE	Rite Aid Corporation	34034d16-dc3b-436d-8ec8-84b3c1f8e48a	2026-06-03	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	St. Mary's Medical Park Pharmacy	f175822d-7ca4-fa33-e053-2995a90ac310	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	68d21d95-9603-4e68-855a-bfc65b1b58c3	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	e53928f3-5181-490b-acfb-be8d4cea60a9	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: FAMOTIDINE generic name: FAMOTIDINE
acid relief	FAMOTIDINE	Rite Aid Corporation	9826dd26-5592-4f96-9274-005ef9462cb4	2026-05-27	Warnings	Name fallback generic name: FAMOTIDINE
CareOne Acid Relief	FAMOTIDINE	American Sales Company	206f5483-7de1-4bc3-af27-190e211bcb95	2026-05-21	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	cf2cd30e-9a0f-4b63-975c-5b551691cda9	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	d0558e97-3bc3-4a1e-9248-1959b0344023	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Famotidine generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43019	ORIG	2003-07-30
30987	ORIG	2001-04-16