Application 022256

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	12.5MG	Yes	No
002	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	25MG	Yes	No
003	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	50MG	Yes	Yes
004	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	100MG	Yes	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	RLD / RS	Approval date
N022256-001	SAVELLA	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14
N022256-002	SAVELLA	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD	2009-01-14
N022256-003	SAVELLA	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14
N022256-004	SAVELLA	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD	2009-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022256-001	AB
N022256-002	AB
N022256-003	AB
N022256-004	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022256-001	7994220	2029-09-19	U-819	2011-09-01
N022256-002	7994220	2029-09-19	U-819
N022256-003	7994220	2029-09-19	U-819
N022256-004	7994220	2029-09-19	U-819

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`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	N022256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	AB	1	`011fe1cb6892…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 332 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	7994220	2029-09-19	U-819		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	7994220	2029-09-19	U-819		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	7994220	2029-09-19	U-819		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-002	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-003	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-004	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-002	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-003	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-004	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	7994220	2029-09-19	U-819		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	7994220	2029-09-19	U-819		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	7994220	2029-09-19	U-819		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-002	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-003	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-004	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	7994220	2029-09-19	U-819		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	7994220	2029-09-19	U-819		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	7994220	2029-09-19	U-819		`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milnacipran Hydrochloride	MILNACIPRAN HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	b66b1850-0d2a-41d6-b0ad-c676166394c7	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256
Savella	MILNACIPRAN HYDROCHLORIDE	Cardinal Health 107, LLC	8b720a1e-034b-4583-b80d-105a794cce74	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256 ndc (product): 55154-4626
Savella	MILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	16a4a314-f97e-4e91-95e9-576a3773d284	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256 ndc (product): 0456-1525 ndc (product): 0456-1500 ndc (product): 0456-1510 ndc (product): 0456-1550 ndc (product): 0456-1512

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-1500	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1500	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1500	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1500	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1500	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1510	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1510	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1510	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1510	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1510	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1512	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1512	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1512	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1512	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1512	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1525	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1525	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1525	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1525	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1525	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1550	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1550	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1550	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1550	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
0456-1550	Savella	milnacipran hydrochloride	Allergan, Inc.	NDA	Current
21695-650	Savella	milnacipran hydrochloride	Rebel Distributors Corp	NDA	Current
21695-651	Savella	milnacipran hydrochloride	Rebel Distributors Corp	NDA	Current
35356-545	Savella	milnacipran hydrochloride	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
50436-9993	Savella	milnacipran hydrochloride	Unit Dose Services	NDA	Current
55154-4626	Savella	milnacipran hydrochloride	Cardinal Health	NDA	Current
55154-4626	Savella	milnacipran hydrochloride	Cardinal Health	NDA	Current
55154-4626	Savella	milnacipran hydrochloride	Cardinal Health 107, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83340	SUPPL	2025-09-11
83339	SUPPL	2025-09-11
83326	SUPPL	2025-09-11
79029	SUPPL	2024-07-09
79028	SUPPL	2024-07-09
75263	SUPPL	2023-08-22
75144	SUPPL	2023-08-21
73634	SUPPL	2023-03-01
73633	SUPPL	2023-03-01
68717	SUPPL	2021-09-22
68684	SUPPL	2021-09-21
68683	SUPPL	2021-09-21
50869	SUPPL	2017-12-27
50816	SUPPL	2017-12-21
50815	SUPPL	2017-12-21
46667	SUPPL	2017-01-05
46651	SUPPL	2017-01-03
45246	SUPPL	2016-09-06
45239	SUPPL	2016-09-06
29483	SUPPL	2015-02-02
17159	SUPPL	2015-01-30
38454	SUPPL	2013-10-31
38453	SUPPL	2013-10-31
29482	SUPPL	2013-10-31
7124	SUPPL	2013-10-31
42470	SUPPL	2013-08-06
38455	SUPPL	2013-06-26
29481	SUPPL	2012-12-11
38452	SUPPL	2012-12-07
29480	SUPPL	2012-11-08
29479	SUPPL	2011-11-10
17158	SUPPL	2011-11-09
7123	SUPPL	2011-05-03
29478	SUPPL	2010-05-21
38451	SUPPL	2010-05-18
17156	SUPPL	2010-02-23
17157	SUPPL	2010-02-16
7122	SUPPL	2010-02-16
7121	SUPPL	2010-02-16
38450	SUPPL	2009-04-23
7120	SUPPL	2009-04-21
42469	ORIG	2009-03-24
44718	ORIG	2009-01-15
17155	ORIG	2009-01-14
7119	ORIG	2009-01-14