Application 078901

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	CAPSULE;ORAL	EQ 25MG BASE;EQ 6MG BASE	No	No
002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	CAPSULE;ORAL	EQ 50MG BASE;EQ 6MG BASE	No	No
003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	CAPSULE;ORAL	EQ 25MG BASE;EQ 12MG BASE	No	No
004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	CAPSULE;ORAL	EQ 50MG BASE;EQ 12MG BASE	No	No
005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	CAPSULE;ORAL	EQ 25MG BASE;EQ 3MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16
A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16
A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16
A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16
A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078901-001	AB
A078901-002	AB
A078901-003	AB
A078901-004	AB
A078901-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078901-001	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078901-002	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 6MG BASE	CAPSULE / ORAL	AB	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078901-003	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078901-004	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 50MG BASE;EQ 12MG BASE	CAPSULE / ORAL	AB	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078901-005	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	EQ 25MG BASE;EQ 3MG BASE	CAPSULE / ORAL	AB	2012-11-16	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A078901-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078901-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078901-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078901-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078901-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078901-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078901-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078901-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078901-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078901-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078901-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078901-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078901-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078901-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078901-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078901-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078901-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078901-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078901-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078901-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078901-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078901-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078901-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078901-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078901-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078901-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078901-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078901-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078901-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078901-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078901-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078901-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078901-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078901-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078901-005	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078901-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078901-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078901-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078901-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078901-005	AB	1	`ea1830bbd6c7…`

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2191	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2191	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2191	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2192	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2192	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2192	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2193	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2193	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2193	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2194	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2194	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2194	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2195	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2195	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current
0781-2195	Olanzapine and Fluoxetine	Olanzapine and Fluoxetine	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9194	ORIG	2012-12-18