Application 220071

Type: ANDA
Sponsor: VIWIT PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A220071-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2026-03-19
A220071-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2026-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A220071-001	AP
A220071-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A220071-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2026-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220071-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2026-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220071-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2026-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220071-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2026-03-19	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220071-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2026-03-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220071-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2026-03-19	`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	A220071-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220071-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220071-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220071-002	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220071-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220071-002	AP	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 14 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SCLERA CARE Topical Anesthetic Gel	LIDOCAINE HYDROCHLORIDE	ScleraCare, LLC	488ace02-fc0b-4d13-ab89-0e1640e915e5	2023-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Theraworx Pain Relief Roll- On- Lidocaine	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	b4ce3876-f9e3-43ca-810b-75fbe6f887b6	2023-10-23	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Bryant Ranch Prepack	ed43f2c3-606c-4998-8fca-ee9b13cd18db	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Accucaine	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	584642a8-9bed-4d86-bfaf-99018c180e34	2023-08-09	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bcdbee5-014e-6b4c-e053-2a91aa0aecd2	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8968c61e-2686-0fe6-e053-2a95a90a15fa	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	858f3faa-e56e-51f9-e053-2a91aa0aa721	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bdd64a8-b90e-57d4-e053-2a91aa0a3911	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6947af02-f4e0-7f9c-e053-2a91aa0a45cd	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86083fea-c064-4ef7-e053-2a91aa0ac17c	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86093c75-6dde-bb16-e053-2991aa0ab6ef	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	79798b21-026d-1b4c-e053-2a91aa0a0129	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	89691444-7bfb-3314-e053-2a95a90a268e	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9c9655fd-89a9-77c8-e053-2a95a90a0c99	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e412b4c-e24f-69ea-e053-2995a90ac600	2023-05-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e049bbe-0f4d-988e-e053-2a95a90a3691	2023-05-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b63614eb-8776-4cd0-e053-2995a90a8f82	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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