Application 208604

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	OINTMENT;TOPICAL	5%	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
A208604-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL			2017-09-20

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.

Product history page 1 of 2 · 43 observed 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	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208604-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208604-001	AT	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A208604-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208604-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208604-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208604-001	AT	1	`ea99ee380514…`

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 7 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	c4c86a8f-1d57-49d2-a65f-acb0dccf2f87	2026-04-21	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Macleods Pharmaceuticals Limited	c788afd3-4554-40c4-8f26-2c31ab9b9b98	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Relivyx Plus	LIDOCAINE	V2 Pharma LLC	08aeb3f5-56ea-4fd7-b151-e6dc65f202da	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Neurocaine	LIDOCAINE	Blue Heron Pharmaceuticals LLC	f36eaded-3155-480c-8723-4b07b6b0790d	2026-04-16	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	Preferred Pharmaceuticals, Inc.	e7ed90d7-11c0-4781-a727-1fe3659a2948	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE generic name: LIDOCAINE
Walgreens Lidocaine Pain Relieving Patch Assorted	LIDOCAINE	Walgreen Co.	41e98f15-669f-4543-e063-6294a90a1ef7	2026-04-15	Warnings	Name fallback generic name: LIDOCAINE
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Name fallback generic name: LIDOCAINE
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	YYBA Corp	5256a84a-8dac-8fd4-e063-6294a90a616c	2026-04-01	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
SPARTAN	LIDOCAINE	TIV PRIME SRL	4e04146a-ed19-2271-e063-6394a90a50f0	2026-03-27	Warnings	Name fallback generic name: LIDOCAINE
Walgreens Pain Relieving Lidocaine	LIDOCAINE	Walgreen Co.	41d5bdc4-66c8-31ab-e063-6394a90a1195	2026-03-27	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Novocol Pharmaceutical of Canada, Inc.	2005680a-8a23-4403-a618-e4ee74fa1121	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE	YYBA Corp	472fe0d1-31a1-fded-e063-6394a90a4a66	2026-03-25	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
EjaGuard	LIDOCAINE	MOLANSPACE INC	475f64ef-d636-7e87-e063-6294a90ae32f	2026-03-25	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	YYBA Corp	4db609cc-f329-62a4-e063-6394a90aefc1	2026-03-23	Warnings	Name fallback brand name: LIDOCAINE generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	DIRECT RX	a575bcb8-478f-1f7e-e053-2995a90a4b12	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	00725e5b-694c-b9e1-e063-6294a90a4182	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_rx	29f211ff-dcba-afb0-e063-6294a90afb9b	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Crane Safety Burn	LIDOCAINE	Crane Safety LLC	96d81566-6321-731e-e053-2995a90ad07d	2026-03-16	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-306	LIDOCAINE	Lidocaine	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-306	LIDOCAINE	Lidocaine	Ingenus Pharmaceuticals, LLC	ANDA	Current