Application 212271

Type: NDA
Sponsor: MEITHEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONTEPO	FOSFOMYCIN DISODIUM	POWDER;INTRAVENOUS	EQ 6GM BASE/VIAL	Yes	Yes

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
N212271-001	CONTEPO	FOSFOMYCIN DISODIUM	EQ 6GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2025-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N212271-001	10086006	2034-10-12	U-4332	2025-11-21
N212271-001	9345717	2034-10-27	U-4332	2025-11-21
N212271-001	11541064	2039-01-30	U-4331	2025-11-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212271-001	NP	2028-10-22
N212271-001	GAIN	2033-10-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212271-001	CONTEPO	EQ 6GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2025-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212271-001	CONTEPO	EQ 6GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2025-10-22	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	CONTEPO	EQ 6GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2025-10-22	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212271-001	10086006	2034-10-12	U-4332	2025-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212271-001	9345717	2034-10-27	U-4332	2025-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212271-001	11541064	2039-01-30	U-4331	2025-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212271-001	10086006	2034-10-12	U-4332	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212271-001	9345717	2034-10-27	U-4332	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212271-001	11541064	2039-01-30	U-4331	2025-11-21	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	10086006	2034-10-12	U-4332	2025-11-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	9345717	2034-10-27	U-4332	2025-11-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	11541064	2039-01-30	U-4331	2025-11-21	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212271-001	NP	2028-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212271-001	GAIN	2033-10-22	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	NP	2028-10-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212271-001	GAIN	2033-10-22	`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
Contepo	FOSFOMYCIN DISODIUM	Meitheal Pharmaceuticals Inc.	855574f2-39f8-43bc-a3d2-79dbb578cb94	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212271 application number: NDA212271

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83905	ORIG	2025-10-23
83902	ORIG	2025-10-23