Application 210771

Type: ANDA
Sponsor: PRINSTON PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOMILNACIPRAN	LEVOMILNACIPRAN	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
002	LEVOMILNACIPRAN	LEVOMILNACIPRAN	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
003	LEVOMILNACIPRAN	LEVOMILNACIPRAN	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
004	LEVOMILNACIPRAN	LEVOMILNACIPRAN	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20
A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20
A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20
A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A210771-001	AB
A210771-002	AB
A210771-003	AB
A210771-004	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 2 of 3 · 104 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210771-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210771-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210771-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210771-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-03-20	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 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	A210771-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210771-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210771-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210771-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210771-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210771-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210771-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210771-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210771-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210771-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210771-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210771-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210771-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210771-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210771-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210771-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210771-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210771-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210771-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210771-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210771-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210771-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210771-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210771-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210771-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210771-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210771-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210771-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210771-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210771-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210771-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210771-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210771-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210771-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210771-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210771-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210771-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210771-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210771-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210771-004	AB	1	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72030	ORIG	2022-09-07