Application 075591

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	FAMOTIDINE	INJECTABLE;INJECTION	0.4MG/ML	No	Yes

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
A075591-001	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	FAMOTIDINE	0.4MG/ML	INJECTABLE / INJECTION		RS	2001-05-10

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A075591-001	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	0.4MG/ML	INJECTABLE / INJECTION	RS	2001-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075591-001	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	0.4MG/ML	INJECTABLE / INJECTION	RS	2001-05-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075591-001	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	0.4MG/ML	INJECTABLE / INJECTION	RS	2001-05-10	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Baxter Healthcare Corporation	97c33213-f415-4718-8466-9aa50371af70	2024-08-20	Adverse reactions	Exact identifier application applno (ANDA): 075591 application number: ANDA075591 ndc (product): 0338-5197

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current
0338-5197	Famotidine	Famotidine	Baxter Healthcare Corporation	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8730	ORIG	2001-05-10