Application 021860

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	Yes	No
003	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021860-001	SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19
N021860-002	SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19
N021860-003	SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021860-002	SARAFEM	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021860-003	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021860-001	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-05-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021860-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021860-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021860-003	AB1	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N021860-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021860-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021860-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021860-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021860-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021860-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021860-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021860-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021860-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021860-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021860-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021860-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021860-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021860-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021860-003	AB1	1	`ea99ee380514…`

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 5 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	be2e4325-feb9-4957-99c0-0a741a2d71a0	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	c4eeae3d-ae56-4e7e-b07d-02851f12039f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	8e822937-9431-446f-88c4-330a25d12439	2023-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	9f069b9b-16e4-4f0e-b420-4aa02ffbb632	2023-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Lannett Company, Inc.	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	2023-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a5d49dee-a7de-44d8-80b5-1aeb89e76938	2023-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	dd659085-c32d-4d35-9d4b-bafa2a93f1fb	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	06582152-d7d3-4e87-8c13-a4416a6ec927	2023-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3453755b-3ed6-47a3-b4c7-c64758e7784c	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9c5112c0-c721-4086-9a75-3b7f931430bb	2023-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	ef699ed0-fd9e-4580-93bb-6fd50499dbd1	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	57f21f2b-0ec2-49dc-911a-806e5ae880c2	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	a6457d6e-5586-40e9-883d-352ee0527d80	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	0cba1992-3990-42a1-9d9a-77b593bbb02e	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	02283de9-6087-45f7-a9ce-3b082ce860de	2019-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Vensun Pharmaceuticals, Inc.	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	2017-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0210	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0210	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0215	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0220	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68731	SUPPL	2021-09-23
68678	SUPPL	2021-09-21
68677	SUPPL	2021-09-21
46799	SUPPL	2017-01-11
46798	SUPPL	2017-01-11
46721	SUPPL	2017-01-06
45046	APPL	2016-08-24
45045	APPL	2016-08-24
16474	SUPPL	2014-12-03
6324	SUPPL	2014-12-02
37775	SUPPL	2013-07-08
37774	SUPPL	2013-07-08
28729	SUPPL	2013-07-08
28728	SUPPL	2013-07-08
28727	SUPPL	2013-07-08
16473	SUPPL	2013-07-08
16472	SUPPL	2013-07-08
6323	SUPPL	2013-07-08
37773	SUPPL	2009-04-28
28726	SUPPL	2009-04-27
42329	ORIG	2008-09-05
37772	SUPPL	2007-12-03
28725	SUPPL	2007-12-03
44157	ORIG	2007-05-09
28724	SUPPL	2007-04-09
16471	SUPPL	2007-04-09
37771	ORIG	2006-05-22
6322	ORIG	2006-05-22