Application 206993

Type: ANDA
Sponsor: CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	No	No
003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A206993-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23
A206993-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23
A206993-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A206993-001	AB1
A206993-002	AB1
A206993-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2019-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206993-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2019-05-23	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206993-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206993-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206993-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206993-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206993-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206993-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206993-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206993-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206993-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206993-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206993-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206993-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206993-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206993-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206993-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206993-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206993-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206993-001	AB1	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	PD-Rx Pharmaceuticals, Inc.	51b8e791-4e9a-4014-b4d8-68fd51ca889f	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993
Fluoxetine	FLUOXETINE	Coupler LLC	50117d4f-0777-54d3-e063-6394a90a857c	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993
Fluoxetine	FLUOXETINE	Cadila Pharmaceuticals Limited	9651816f-58f5-4bf8-8183-6f3d84d36b5c	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993 ndc (product): 71209-040 ndc (product): 71209-041 ndc (product): 71209-042
Fluoxetine	FLUOXETINE	Modavar Pharmaceuticals LLC	05b0781b-50e2-4311-bde0-430b96e2ef8e	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206993 application number: ANDA206993 ndc (product): 72241-009 ndc (product): 72241-008 ndc (product): 72241-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-040	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-040	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-040	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-040	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-040	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-041	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-041	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-041	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-041	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-041	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-042	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-042	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-042	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-042	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-042	Fluoxetine	Fluoxetine	Cadila Pharmaceuticals Limited	ANDA	Current
72241-007	Fluoxetine	Fluoxetine	Modavar Pharmaceuticals LLC	ANDA	Current
72241-008	Fluoxetine	Fluoxetine	Modavar Pharmaceuticals LLC	ANDA	Current
72241-009	Fluoxetine	Fluoxetine	Modavar Pharmaceuticals LLC	ANDA	Current