Application 208660

Type: ANDA
Sponsor: DR REDDYS

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
A208660-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2021-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208660-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208660-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-01-05	`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	A208660-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208660-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208660-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208660-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208660-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208660-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208660-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208660-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208660-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208660-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208660-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208660-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208660-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208660-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208660-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208660-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208660-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208660-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208660-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208660-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208660-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208660-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208660-001	AT	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208660-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208660-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208660-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208660-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208660-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208660-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208660-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208660-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208660-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208660-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208660-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208660-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208660-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208660-001	AT	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 5 of 26 · 504 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	54df7353-5411-43ad-bd7b-a3d4d62c72c6	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	4806f94d-cbac-4107-b93b-8f715868ffb3	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	323e0ec2-c2e5-47d1-a39f-69ff5c99e324	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	522f1521-f9f2-4c26-e063-6394a90a9e05	2026-05-19	Warnings	Name fallback generic name: LIDOCAINE
Burn Relief	LIDOCAINE	WALMART INC.	15af4557-4baf-c177-e063-6294a90a7a5b	2026-05-18	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE PAIN RELIEF Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	01ff3442-5a4e-4013-e063-6294a90a809e	2026-05-17	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE PAIN RELIEF Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	247ecba5-196b-0179-e063-6394a90a0371	2026-05-17	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE PAIN RELIEF Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	322aa97d-b35b-d9dd-e063-6394a90a7ae5	2026-05-17	Warnings	Name fallback generic name: LIDOCAINE
KY Duration for Him	LIDOCAINE	Reckitt Benckiser LLC	83cc86bd-3303-4956-a198-fae85b6e34e1	2026-05-15	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Knee Pain Relief Patch	LIDOCAINE	Guangzhou Sumi Technology Innovation Co., Ltd	4fdbc841-ee84-c1b3-e063-6294a90a6f5c	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel -Patch	LIDOCAINE	Guangzhou Sumi Technology Innovation Co., Ltd	514900f1-7fcb-636a-e063-6394a90a4ba2	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Gel-Roll On	LIDOCAINE	Trifecta Pharmaceuticals USA	51cb6797-55ec-7a7a-e063-6294a90a90ee	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	412fd7c8-1e05-1779-e063-6294a90a3de4	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	433ac435-279e-574b-e063-6294a90a1d6d	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	3ef5bfac-0c05-b703-e063-6394a90a2276	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	3737cd00-0582-94e6-e063-6394a90a6280	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f1045448-ae78-eba6-e053-2a95a90a6793	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	fd0d4646-4b5e-3fe8-e053-6394a90ad6c4	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	0897cc86-c775-8821-e063-6394a90a6fcf	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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