Application 203708

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A203708-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15
A203708-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203708-001	AB
A203708-002	AB
A203708-003	AB
A203708-004	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	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-05-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203708-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203708-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203708-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203708-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203708-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203708-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203708-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203708-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203708-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203708-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203708-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203708-004	AB	1	`5bbf6a4d5a75…`

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	Aurobindo Pharma Limited	4d768cfe-3b20-4127-95b9-b4151b28afcc	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203708 application number: ANDA203708 ndc (product): 65862-656 ndc (product): 65862-658 ndc (product): 65862-657 ndc (product): 65862-659

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-656	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-656	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-656	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-656	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-657	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-657	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-657	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-657	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-658	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-658	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-658	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-658	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-659	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-659	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-659	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
65862-659	Olanzapine	Olanzapine	Aurobindo Pharma Limited	ANDA	Current
66993-686	Olanzapine	Olanzapine	Prasco Laboratories	ANDA	Current
66993-687	Olanzapine	Olanzapine	Prasco Laboratories	ANDA	Current
66993-688	Olanzapine	Olanzapine	Prasco Laboratories	ANDA	Current
66993-689	Olanzapine	Olanzapine	Prasco Laboratories	ANDA	Current