Application 211484

Type: ANDA
Sponsor: VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	TABLET;ORAL	2MG	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
A211484-001	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2018-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211484-001	AB

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	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211484-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB	2018-12-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211484-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211484-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211484-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211484-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211484-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211484-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211484-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211484-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211484-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211484-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211484-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211484-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211484-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211484-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211484-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211484-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211484-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211484-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211484-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211484-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211484-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211484-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211484-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211484-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211484-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211484-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211484-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211484-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211484-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211484-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211484-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211484-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211484-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211484-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211484-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211484-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211484-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211484-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211484-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211484-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211484-001	CGT	2019-06-11	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211484-001	CGT	2019-06-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211484-001	CGT	2019-06-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211484-001	CGT	2019-06-11	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levorphanol Tartrate	LEVORPHANOL TARTRATE	Bryant Ranch Prepack	deed8652-9b9d-48b4-8c3e-9fdd7c46237e	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211484 application number: ANDA211484
Levorphanol Tartrate	LEVORPHANOL TARTRATE	Virtus Pharmaceuticals, LLC	6e7ca993-c8b9-4510-a2b0-5bcc678d2571	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211484 application number: ANDA211484 ndc (product): 69543-417
Levorphanol Tartrate	LEVORPHANOL TARTRATE	ACERTIS PHARMACEUTICALS, LLC	113a713f-830b-481c-bfa6-d44e3ac27f80	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211484 application number: ANDA211484

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-412	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-417	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-417	Levorphanol Tartrate	Levorphanol Tartrate	Virtus Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76432	ORIG	2023-11-07
57263	ORIG	2019-01-18