Application 021717

Type: NDA
Sponsor: TARO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLIAGLIS	LIDOCAINE; TETRACAINE	CREAM;TOPICAL	7%;7%	Yes	Yes

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
N021717-001	PLIAGLIS	LIDOCAINE; TETRACAINE	7%;7%	CREAM / TOPICAL		RLD, RS	2006-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021717-001	10350180	2031-01-14		Drug product	2019-11-04
N021717-001	10603293	2031-01-14		Drug product	2020-04-14
N021717-001	10751305	2031-01-14		Drug product	2020-09-21
N021717-001	12558328	2031-01-14	U-4421		2026-03-04

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD	2006-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021717-001	PLIAGLIS	7%;7%	CREAM / TOPICAL	RLD, RS	2006-06-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021717-001	12558328	2031-01-14	U-4421		2026-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021717-001	12558328	2031-01-14	U-4421		2026-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021717-001	10751305	2031-01-14		Drug product	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021717-001	10350180	2031-01-14		Drug product	2019-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021717-001	10603293	2031-01-14		Drug product	2020-04-14	`79d66fd596c7…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PLIAGLIS	LIDOCAINE AND TETRACAINE	IPG PHARMACEUTICALS, INC.	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021717 application number: NDA021717

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-6100	PLIAGLIS	lidocaine and tetracaine	Galderma Laboratories, L.P.	NDA	Current
51672-5305	PLIAGLIS	Lidocaine and Tetracaine	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current
51672-5305	PLIAGLIS	Lidocaine and Tetracaine	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current
51672-5305	PLIAGLIS	Lidocaine and Tetracaine	Taro Pharmaceuticals U.S.	NDA	Current
69420-3077	LIDOCAINE AND TETRACAINE	LIDOCAINE AND TETRACAINE	SA3, LLC	NDA AUTHORIZED GENERIC	Current
69420-3077	Lidocaine and Tetracaine	lidocaine and tetracaine	SAE, LLC	NDA AUTHORIZED GENERIC	Current
71800-631	Lidocaine and Tetracaine	Lidocaine and Tetracaine	Innovida Pharmaceutique Corporation	NDA AUTHORIZED GENERIC	Current
71800-631	Lidocaine and Tetracaine	Lidocaine and Tetracaine	Innovida Pharmaceutique Corporation	NDA AUTHORIZED GENERIC	Current
71800-631	Lidocaine and Tetracaine	Lidocaine and Tetracaine	Innovida Pharmaceutique Corporation	NDA AUTHORIZED GENERIC	Current
71800-631	Lidocaine and Tetracaine	Lidocaine and Tetracaine	Innovida Pharmaceutique Corporation	NDA AUTHORIZED GENERIC	Current
73575-009	Pliaglis	lidocaine and tetracaine	Oba Pharmaceuticals, Inc.	NDA	Current
73575-009	Pliaglis	lidocaine and tetracaine	Oba Pharmaceuticals, Inc.	NDA	Current
73575-010	Pliaglis	lidocaine and tetracaine	Oba Pharmaceuticals, Inc.	NDA	Current
73575-010	Pliaglis	lidocaine and tetracaine	Oba Pharmaceuticals, Inc.	NDA	Current
73575-010	Pliaglis	lidocaine and tetracaine	Oba Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56861	SUPPL	2018-12-20
56708	SUPPL	2018-12-12
56364	SUPPL	2018-11-08
56272	SUPPL	2018-11-05
50497	SUPPL	2017-11-27
50481	SUPPL	2017-11-24
37512	SUPPL	2013-11-15
6040	SUPPL	2013-11-12
42283	ORIG	2008-10-15
37511	SUPPL	2007-07-05
28451	SUPPL	2007-07-05
16250	ORIG	2006-07-03
6039	ORIG	2006-07-03