Application 020971

Type: NDA
Sponsor: DEPROCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	Yes	Yes
002	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020971-001	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03
N020971-002	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`87673890dc5c…`

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	N020971-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020971-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020971-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020971-001	AP	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 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	636cbf11-819c-48f8-915d-ac5fb38bd352	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Septocaine and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Septodont Inc.	0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 0362-9049 ndc (product): 0362-9048
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	fc908011-5e5e-459a-a666-d41426504703	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Zorcaine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	1767d606-69b8-419e-840f-36550ed91b8f	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 0362-0830
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	2b5a7ee3-71ee-4c41-ad9f-852f170470b3	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 50227-1050
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	0b0cbbec-8216-434f-892e-226c89d7239c	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 43128-101
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	cc7ff594-2204-44b2-8f81-bcb9c7e9360b	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	f26a084b-ab25-4ca2-8f58-705a4219bf32	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	406de6e6-40f5-44c5-a109-3be0b9d48e58	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 50227-1040
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 43128-102
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	d47d7842-930e-41db-9631-d1aba0f05ae0	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 66975-417
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein	d9402ac2-fedd-4fb0-90a3-2c466a786526	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 0404-6625 ndc (product): 0404-6620
Articadent	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 66312-601 ndc (product): 66312-602
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	c4bba4ab-2b20-43e6-92ea-9ec6f1fce754	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	854399ec-f7d6-4eab-87bb-94c2b442ec3e	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	4524cb96-40f7-471f-bfc6-1dcab47628ec	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 66975-418

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0362-0830	Zorcaine	Articaine Hydrochloride and Epinephrine	Septodont, Inc.	NDA	Current
0362-0830	Zorcaine	Articaine Hydrochloride and Epinephrine	Septodont, Inc.	NDA	Current
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9048	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9049	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9049	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9049	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0362-9049	Septocaine and Epinephrine	Articaine Hydrochloride and Epinephrine Bitartrate	Septodont Inc.	NDA	Current
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6620	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6625	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6625	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6625	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
0404-6625	Articaine Hydrochloride and Epinephrine	Articaine Hydrochloride and Epinephrine	Henry Schein	NDA	Current
31382-830	Zorcaine	Articaine hydrochloride and Epinephrine Bitartrate	Carestream Health, Inc.	NDA	Current
43128-101	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
43128-101	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
43128-101	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
43128-102	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
43128-102	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
43128-102	ARTICAINE	Articaine Hydrochloride and Epinephrine	NDC, Inc.	NDA	Current
50227-1040	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
50227-1040	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
50227-1040	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
50227-1050	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
50227-1050	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
50227-1050	ARTICAINE	Articaine Hydrochloride and Epinephrine	Patterson Dental	NDA	Current
66312-601	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	ANDA	Current
66312-601	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	NDA	Current
66312-601	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	NDA	Current
66312-602	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	ANDA	Current
66312-602	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	NDA	Current
66312-602	Articadent	Articaine hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	NDA	Current
66975-417	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current
66975-417	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current
66975-417	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current
66975-418	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current
66975-418	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current
66975-418	ARTICAINE	Articaine Hydrochloride and Epinephrine	Benco Dental	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56378	SUPPL	2018-11-08
56266	SUPPL	2018-11-05
21311	SUPPL	2015-01-28
21310	SUPPL	2015-01-28
41847	SUPPL	2013-06-03
21309	SUPPL	2013-06-03
3869	SUPPL	2010-11-18
35732	SUPPL	2010-03-03
3868	SUPPL	2010-02-26
26311	SUPPL	2006-11-14
13829	SUPPL	2006-11-13
3867	SUPPL	2005-02-08
3866	SUPPL	2004-10-18
21308	ORIG	2002-08-14
13828	ORIG	2000-04-03
3865	ORIG	2000-04-03