Application 210826

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 20MG BASE	No	No
002	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 40MG BASE	No	No
003	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No
004	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 120MG BASE	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	Approval date
A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06
A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06
A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06
A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06

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 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210826-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210826-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210826-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210826-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2023-01-06	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A210826-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210826-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210826-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210826-004	AB	1	`3bdfa0b2c4d7…`

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
Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	f371258d-91b3-4b6a-ac99-434a1964c3af	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOMILNACIPRAN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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