Application 206155

Type: ANDA
Sponsor: INDOCO REMEDIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET;ORAL	2.5MG	No	No
002	OLANZAPINE	OLANZAPINE	TABLET;ORAL	5MG	No	No
003	OLANZAPINE	OLANZAPINE	TABLET;ORAL	7.5MG	No	No
004	OLANZAPINE	OLANZAPINE	TABLET;ORAL	10MG	No	No
005	OLANZAPINE	OLANZAPINE	TABLET;ORAL	15MG	No	No
006	OLANZAPINE	OLANZAPINE	TABLET;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206155-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31
A206155-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31
A206155-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31
A206155-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31
A206155-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31
A206155-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31

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 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-005	OLANZAPINE	15MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206155-006	OLANZAPINE	20MG	TABLET / ORAL	2020-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-001	OLANZAPINE	2.5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-002	OLANZAPINE	5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-003	OLANZAPINE	7.5MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206155-004	OLANZAPINE	10MG	TABLET / ORAL	2020-07-31	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206155-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206155-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206155-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206155-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206155-006	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206155-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206155-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206155-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206155-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206155-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206155-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206155-004	AB	1	`5aa47cf7b7d7…`

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 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Direct_Rx	fcec190f-b865-c5d3-e053-6394a90a7e45	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Direct_Rx	22528ae1-e36f-48e1-e063-6294a90a3dd2	2024-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	ea3259d5-36ee-4ac9-b849-9625626e2187	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	NorthStar RxLLC	f4e41c2c-d32d-40c2-8afb-b6df998ba6b0	2023-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Lannett Company, Inc.	002dd00f-7946-ea4f-e063-6294a90a5916	2023-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	09e48e71-4dd2-4538-91d7-5b284f6647d8	2023-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Dr. Reddy's Laboratories Ltd.	9a57a63e-f856-aafa-037a-c08f2fea6496	2022-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	61424fa3-b09a-4267-a208-a7c7c3f69fe5	2020-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Olanzapine generic name: OLANZAPINE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14445-106	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
14445-107	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
14445-108	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
14445-109	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
14445-110	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
14445-111	Olanzapine	Olanzapine	Indoco Remedies Limited	ANDA	Current
51293-847	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-847	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-848	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-848	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-849	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-849	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-850	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-850	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-851	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-851	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-852	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current
51293-852	Olanzapine	Olanzapine	ECI PHARMACEUTICALS LLC	ANDA	Current