Application 080198

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	OINTMENT;TOPICAL	5%	No	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
A080198-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080198-001	AT

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	A080198-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	RLD, RS, Approved before 1982		`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	A080198-001	AT	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Fougera Pharmaceuticals, LLC	88ca9cba-0c4a-482f-b502-ceefdb1bfbcd	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080198 application number: ANDA080198 ndc (product): 0168-0204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0204	Lidocaine	Lidocaine	Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0204	Lidocaine	Lidocaine	Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0204	Lidocaine	Lidocaine	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
21695-826	Lidocaine	Lidocaine	Rebel Distributors Corp	ANDA	Current
33261-564	Lidocaine	Lidocaine	Aidarex Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43159	SUPPL	2015-03-11