Application 213906

Type: ANDA
Sponsor: SUN PHARM INDS INC

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	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
A213906-001	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17
A213906-002	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		RS	2023-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213906-001	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 · 55 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	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		RS	2023-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		RS	2023-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL		RS	2023-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213906-002	LEVORPHANOL TARTRATE	3MG	TABLET / ORAL	AB		2023-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213906-001	LEVORPHANOL TARTRATE	2MG	TABLET / ORAL	AB		2021-06-17	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 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	A213906-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213906-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213906-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213906-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213906-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213906-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213906-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213906-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213906-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213906-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213906-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213906-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213906-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213906-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213906-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213906-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213906-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213906-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213906-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213906-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213906-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213906-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213906-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213906-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213906-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213906-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213906-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213906-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213906-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213906-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213906-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213906-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213906-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213906-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213906-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213906-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213906-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213906-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213906-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213906-002	AB	1	`9b2671bbb829…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levorphanol Tartrate	LEVORPHANOL TARTRATE	Sun Pharmaceutical Industries, Inc.	438cf3ea-04fe-4626-9f0f-adcda7633651	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213906 application number: ANDA213906 ndc (product): 57664-762

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-762	Levorphanol Tartrate	Levorphanol Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current