Application 075669

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML	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
A075669-001	FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION			2001-04-16

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075669-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	2001-04-16	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a0f38398-4d34-4ecc-8a6a-37732adaaad3	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Ascend Laboratories, LLC	b2228be0-472b-4e47-9910-af0bf12fde77	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	HAWAII REPACK, INC.	eec89230-47fc-4139-a370-b4f9e225e8c0	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Advanced Rx of Tennessee, LLC	5648ca13-1add-56ec-e063-6294a90a6f29	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
CareOne Acid Relief	FAMOTIDINE	American Sales Company	ed474c9d-c08b-4f52-8b24-5887978e4275	2026-07-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Redpharm Drug	55730918-d9e8-eaad-e063-6394a90aeda2	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Signature Care Acid Controller maximum strength	FAMOTIDINE	Safeway	ca5edcf8-1ed2-403a-a01b-0deb692bee0c	2026-06-30	Warnings	Name fallback generic name: FAMOTIDINE
Zantac 360	FAMOTIDINE	Select Consumer Group LLC	529cef2d-e6cc-3b37-e063-6294a90aff59	2026-06-27	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sportpharm LLC	4421ceb7-a114-436c-871a-7bc5444f8154	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	CVS Pharmacy, Inc.	7357f67e-0fc6-4555-aa8b-1df09cba9feb	2026-06-24	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Family Dollar Stores, LLC	4dc7c2c4-83c7-608d-e063-6294a90a90eb	2026-06-23	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Unit Dose Solutions, Inc.	54d93bf1-8f9a-981b-e063-6394a90a0fde	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	TWIN MED LLC	795afb99-a3f4-4ffc-a905-2f84f3d86e4c	2026-06-16	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	TWIN MED LLC	6d97c60e-e39d-4541-ab49-d0fe3b3fa840	2026-06-16	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Safecor Health, LLC	1b5cb132-d28f-4fbe-91f5-dc04f9a551d1	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	e59a2c97-19c7-485c-bb1b-272ddb9ae053	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	32fd4101-15cb-411e-8b9d-270ec0592c6e	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	31cdc900-fe17-2d5f-e063-6294a90a0fda	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sagent Pharmaceuticals	9710995d-b518-40ce-bc2b-8b5dcf002c31	2026-06-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid relief	FAMOTIDINE	Rite Aid Corporation	8c6d5419-088b-4b3e-80b8-2a0d06926ff1	2026-06-03	Warnings	Name fallback generic name: FAMOTIDINE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8757	ORIG	2004-06-04
8758	ORIG	2001-04-16