Application 213479

Type: ANDA
Sponsor: NOVITIUM PHARMA

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
002	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	TABLET;ORAL	3MG	No	No
003	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213479-001	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX	2020-07-01
A213479-002	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX	2021-01-12
A213479-003	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX	2021-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213479-001	BX
A213479-002	BX
A213479-003	BX

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 3 · 111 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
2026-09-14 22:38:34	2026-08	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX		2020-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX		2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX		2021-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX		2020-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX		2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX		2021-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX		2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX		2021-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX		2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX		2021-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	BX		2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	BX		2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL	BX		2021-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213479-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB	RS	2021-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213479-003	LEVORPHANOL TARTRATE	1MG	TABLET / ORAL			2021-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213479-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2020-07-01	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A213479-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213479-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213479-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213479-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213479-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213479-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213479-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213479-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213479-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213479-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213479-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213479-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213479-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213479-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213479-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213479-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213479-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213479-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213479-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213479-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213479-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213479-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213479-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213479-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213479-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213479-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213479-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213479-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213479-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213479-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213479-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213479-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213479-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213479-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213479-001	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213479-002	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213479-003	BX	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 · 2 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	d7587868-561c-4e04-b02c-36a4b653a762	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213479 application number: ANDA213479 ndc (product): 63629-2093
Levorphanol Tartrate	LEVORPHANOL TARTRATE	Lannett Company, Inc.	a50debe1-90b3-4931-9ec0-67e88dd21b04	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213479 application number: ANDA213479 ndc (product): 0527-3237 ndc (product): 0527-3236

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 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-3236	Levorphanol Tartrate	Levorphanol Tartrate	Lannett Company, Inc.	ANDA	Current
0527-3236	Levorphanol Tartrate	Levorphanol Tartrate	Lannett Company, Inc.	ANDA	Current
0527-3236	Levorphanol Tartrate	Levorphanol Tartrate	Lannett Company, Inc.	ANDA	Current
0527-3237	Levorphanol Tartrate	Levorphanol Tartrate	Lannett Company, Inc.	ANDA	Current
0527-3237	Levorphanol Tartrate	Levorphanol Tartrate	Lannett Company, Inc.	ANDA	Current
63629-2093	Levorphanol Tartrate	Levorphanol Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-2093	Levorphanol Tartrate	Levorphanol Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-2093	Levorphanol Tartrate	Levorphanol Tartrate	Bryant Ranch Prepack	ANDA	Current
70954-236	Levorphanol Tartrate	Levorphanol Tartrate	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76461	ORIG	2023-11-07