Application 212435

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	INJECTABLE;INJECTION	500MG/100ML	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
A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE / INJECTION	AP		2020-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212435-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A212435-001	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP		2020-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A212435-001	AP	1	`a50c72e98297…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METRONIDAZOLE	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	7187779a-1f4c-4607-af53-4119e324aad5	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212435 application number: ANDA212435 ndc (product): 47335-993
Metronidazole	METRONIDAZOLE	Gland Pharma Limited	74cf111a-9b83-4f93-b0e8-bc252d471d43	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212435 application number: ANDA212435 ndc (product): 68083-373

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
47335-993	METRONIDAZOLE	metronidazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-993	METRONIDAZOLE	metronidazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68083-373	Metronidazole	Metronidazole	Gland Pharma Limited	ANDA	Current
68083-373	Metronidazole	Metronidazole	Gland Pharma Limited	ANDA	Current
68083-373	Metronidazole	Metronidazole	Gland Pharma Limited	ANDA	Current
68083-373	Metronidazole	Metronidazole	Gland Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64393	ORIG	2020-08-24