Application 016964

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	Yes	Yes
004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.25%;0.0091MG/ML	Yes	Yes
005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	Yes	Yes
006	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	Yes	Yes
007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.5%;0.0091MG/ML	Yes	Yes
008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.5%;0.0091MG/ML	Yes	Yes
009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.75%	Yes	Yes
010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.75%;0.0091MG/ML	Yes	Yes
012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	Yes	Yes
013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.25%;0.0091MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016964-001	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-006	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 10 matching rows.

Application-product, TE code table
Application-product	TE code
N016964-001	AP
N016964-004	AP
N016964-005	AP
N016964-006	AP
N016964-007	AP
N016964-008	AP
N016964-009	AP
N016964-010	AP
N016964-012	AP
N016964-013	AP

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 7 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016964-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-005	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-006	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-007	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-008	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-009	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-010	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-012	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016964-013	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016964-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-009	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-010	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-012	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-013	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016964-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-012	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-013	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016964-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-012	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-013	AP	1	`011fe1cb6892…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	562f4499-f3b7-4d9e-b022-61172176c883	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	67578b56-7540-487e-1fba-481255620e78	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964 ndc (product): 0409-1559 ndc (product): 0409-1560 ndc (product): 0409-1752 ndc (product): 0409-1610 ndc (product): 0409-1582 ndc (product): 0409-1755 ndc (product): 0409-1749 ndc (product): 0409-1746 ndc (product): 0409-1587
MARCAINE WITH EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein, Inc.	d0d51133-882c-4f9e-ba1c-f037226305a1	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964 ndc (product): 0404-9908
Marcaine	BUPIVACINE HYDROCHLORIDE	Henry Schein, Inc.	7d94e8e0-0d1e-4af3-973a-a480d7d51737	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	93cf0914-de08-4ec6-8f8c-d663243b9958	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964 ndc (product): 0409-1541

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 2 · 131 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9906	Marcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9906	Marcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9907	Marcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9907	Marcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9907	Marcaine	Bupivacaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9908	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate	Henry Schein, Inc.	NDA	Current
0404-9908	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate	Henry Schein, Inc.	NDA	Current
0409-1541	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	NDA	Current
0409-1541	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1559	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1560	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1582	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1587	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1610	Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64445	SUPPL	2020-08-28
64375	SUPPL	2020-08-24
56320	SUPPL	2018-11-06
56259	SUPPL	2018-11-05
519	SUPPL	2012-02-01
10943	SUPPL	2012-01-30
10942	SUPPL	2010-02-25
518	SUPPL	2010-02-25
13062	SUPPL	2005-11-01
10941	SUPPL	2005-11-01