Application 200221

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	No	No
002	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
003	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No
004	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200221-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12
A200221-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12
A200221-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12
A200221-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200221-001	AB
A200221-002	AB
A200221-003	AB
A200221-004	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 5 · 172 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	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200221-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200221-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200221-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200221-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2012-09-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A200221-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200221-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200221-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200221-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200221-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200221-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200221-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200221-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200221-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200221-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200221-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200221-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200221-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200221-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200221-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200221-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200221-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200221-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200221-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200221-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200221-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200221-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200221-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200221-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200221-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200221-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200221-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200221-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200221-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200221-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200221-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200221-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200221-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200221-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200221-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200221-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200221-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200221-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200221-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200221-004	AB	1	`6a51e52b5d6a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Jubilant Cadista Pharmacuticals Inc.	028aa88e-fa50-7aa8-cc0b-97c0c9a0357c	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200221 application number: ANDA200221 ndc (product): 59746-307 ndc (product): 59746-306 ndc (product): 59746-309 ndc (product): 59746-308

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6111	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
59746-306	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-306	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-307	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-307	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-308	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-308	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-309	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
59746-309	Olanzapine	Olanzapine	Jubilant Cadista Pharmaceuticals Inc	ANDA	Current
63629-7514	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-7514	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current