Application 205318

Type: ANDA
Sponsor: TELIGENT PHARMA INC

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 1.

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
A205318-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205318-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A205318-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205318-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205318-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205318-001	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDICAINE	Encube Ethicals, Inc.	e9f80c8a-05ba-47f8-aff1-e2583b2f8e57	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	c18f0c2b-cd05-4458-888f-47b4a1106937	2020-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318 ndc (product): 76420-131
Lidocaine	LIDOCAINE	Proficient Rx LP	cbf01b82-c43f-4bed-a1df-7569f4816c76	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318 ndc (product): 71205-342

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0028	Lidocaine 5%	Lidocaine 5% cream	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0028	Lidocaine 5%	Lidocaine 5% cream	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50383-341	Lidocaine	lidocaine	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-341	Lidocaine	lidocaine	Akorn	ANDA	Current
52565-008	Lidocaine	lidocaine	Teligent Pharma, Inc.	ANDA	Current
53217-248	Lidocaine	lidocaine	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-464	Lidocaine	lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-464	Lidocaine	lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59088-811	DermacinRx Lido V Pak	Lidocaine	PureTek Corporation	ANDA	Current
59088-811	DermacinRx Lido V Pak	Lidocaine	PureTek Corporation	ANDA	Current
61919-774	LIDOCAINE	LIDOCAINE	DIRECTRX	ANDA	Current
61919-774	LIDOCAINE	LIDOCAINE	DIRECTRX	ANDA	Current
68071-4628	Lidocaine	lidocaine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4628	Lidocaine	lidocaine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6430	Lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7486	Lidocaine 5%	Lidocaine 5% cream	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7486	Lidocaine 5%	Lidocaine 5% cream	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7486	Lidocaine 5%	Lidocaine 5% cream	Preferred Pharmaceuticals Inc.	ANDA	Current
69621-821	Zeyocaine	lidocaine, isopropyl alcohol	Shoreline Pharmaceuticals, Inc.	ANDA	Current
70512-027	Lidocaine 5%	Lidocaine 5% cream	KBS Solutions, LLC	ANDA	Current
70512-027	Lidocaine 5%	Lidocaine 5% cream	KBS Solutions, LLC	ANDA	Current
70512-027	Lidocaine 5%	Lidocaine 5% cream	SOLA Pharmaceuticals	ANDA	Current
70512-027	Lidocaine 5%	Lidocaine 5% cream	SOLA Pharmaceuticals	ANDA	Current
70518-2355	Lidocaine	lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2355	Lidocaine	lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2355	Lidocaine	lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2355	Lidocaine	lidocaine	REMEDYREPACK INC.	ANDA	Current
71205-342	Lidocaine	lidocaine	Proficient Rx LP	ANDA	Current
72275-716	Lidovix L	Lidocaine 5%	Primary Pharmaceuticals, Inc.	ANDA	Current
72275-716	Lidovix L	Lidocaine 5%	Primary Pharmaceuticals, Inc.	ANDA	Current
73272-300	LidoStream	Lidocaine 5% Ointment and Menthol 10% Topical Liquid	Upstream Pharma, LLC	ANDA	Current
76420-131	Lidocaine	lidocaine	Asclemed USA, Inc.	ANDA	Current
80175-0008	lidocaine	lidocaine	Central Packaging	ANDA	Current
80175-0008	lidocaine	lidocaine	Central Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10435	ORIG	2016-02-03