Application 205081

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205081-001	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2016-04-22
A205081-002	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-04-22
A205081-003	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-04-22
A205081-004	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205081-001	AB
A205081-002	AB
A205081-003	AB
A205081-004	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 1 of 5 · 164 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	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205081-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-004	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-004	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milnacipran Hydrochloride	MILNACIPRAN HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	e39b4890-99e4-4e48-9f45-978d5ac9f402	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Milnacipran Hydrochloride generic name: MILNACIPRAN HYDROCHLORIDE
Milnacipran Hydrochloride	MILNACIPRAN HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	b66b1850-0d2a-41d6-b0ad-c676166394c7	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Milnacipran Hydrochloride generic name: MILNACIPRAN HYDROCHLORIDE
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	99efa59a-8458-4e04-8cb1-20abfc179228	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MILNACIPRAN HYDROCHLORIDE generic name: MILNACIPRAN HYDROCHLORIDE
Savella	MILNACIPRAN HYDROCHLORIDE	Cardinal Health 107, LLC	8b720a1e-034b-4583-b80d-105a794cce74	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MILNACIPRAN HYDROCHLORIDE
Savella	MILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	16a4a314-f97e-4e91-95e9-576a3773d284	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MILNACIPRAN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-091	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-092	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-093	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current
65162-094	Milnacipran HCl	Milnacipran HCl	Amneal Pharmaceuticals LLC	ANDA	Current