Application 089407

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POLOCAINE	MEPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	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
A089407-001	POLOCAINE	MEPIVACAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RS	1986-12-01

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION		RS	1986-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION			1986-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION			1986-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089407-001	POLOCAINE	1%	INJECTABLE / INJECTION	AP		1986-12-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089407-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089407-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089407-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089407-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089407-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089407-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089407-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089407-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089407-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089407-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089407-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089407-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089407-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089407-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089407-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089407-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089407-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089407-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089407-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089407-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089407-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089407-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089407-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089407-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089407-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089407-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089407-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089407-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089407-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089407-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089407-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089407-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089407-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089407-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089407-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089407-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089407-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POLOCAINE (MEPIVACAINE HCl)	POLOCAINE (MEPIVACAINE HCL)	HF Acquisition Co LLC, DBA HealthFirst	c21a4c3a-82c0-0bfb-e053-2995a90a2b65	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089407 application number: ANDA089407 ndc (product): 51662-1534
Polocaine-MPF	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a27d0815-ae6b-4a21-a8f5-564c01e83814	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089407 application number: ANDA089407 ndc (product): 63323-283

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4517	Polocaine	MEPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-4517	Polocaine	MEPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
51662-1534	POLOCAINE (MEPIVACAINE HCl)	POLOCAINE (MEPIVACAINE HCl)	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1534	POLOCAINE (MEPIVACAINE HCl)	POLOCAINE (MEPIVACAINE HCl)	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-283	Polocaine	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-283	Polocaine	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-283	Polocaine	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current