Application 217221

Type: ANDA
Sponsor: DIFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	PATCH;TOPICAL	1.8%	No	No

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
A217221-001	LIDOCAINE	LIDOCAINE	1.8%	PATCH / TOPICAL	AB		2025-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217221-001	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217221-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217221-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217221-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217221-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217221-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217221-001	AB	1	`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 19 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Name fallback generic name: LIDOCAINE
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief 4% Lidocaine	LIDOCAINE	Unexo Life Sciences Private Limited	bfee9be1-b265-44bd-8e82-2ec27132f82b	2025-01-13	Warnings	Name fallback generic name: LIDOCAINE
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Name fallback generic name: LIDOCAINE
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Name fallback generic name: LIDOCAINE
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18bae4a-11ac-7319-e053-2995a90ad1e8	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
LMR Plus	LIDOCAINE	V2 Pharma, LLC	7c84e443-67fe-40b5-b721-86e9e7c4d490	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	f7ada189-7463-4bc7-83e7-f140558ecacf	2024-12-25	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	Quality Care Products, LLC	38f31902-99fd-4a63-853e-b5f93dfc5980	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Quality Care Products, LLC	7bb5c092-91da-4789-b348-58548703d716	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Name fallback generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete	LIDOCAINE	Scholl's Wellness Company LLC	26e3a678-b28f-588b-e063-6394a90ac025	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete	LIDOCAINE	Scholl's Wellness Company LLC	d860b339-48a0-405c-a67d-f7e7a31f6351	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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