Application 202295

Type: ANDA
Sponsor: ALKEM LABS LTD

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 42.

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	TE codes	Approval date
A202295-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20
A202295-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20
A202295-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20
A202295-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20
A202295-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20
A202295-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202295-001	AB
A202295-002	AB
A202295-003	AB
A202295-004	AB
A202295-005	AB
A202295-006	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 7 · 252 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	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2015-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2015-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2015-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2015-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2015-10-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 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	A202295-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202295-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202295-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202295-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202295-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202295-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202295-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202295-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202295-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202295-004	AB	1	`03ed91905a0d…`

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	Ascend Laboratories, LLC	e8626e68-088d-47ff-bf06-489a778815aa	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202295 application number: ANDA202295 ndc (product): 67877-172 ndc (product): 67877-177 ndc (product): 67877-173 ndc (product): 67877-175 ndc (product): 67877-174 ndc (product): 67877-176

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-172	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-172	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-173	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-173	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-174	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-174	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-175	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-175	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-176	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-176	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-177	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current
67877-177	Olanzapine	Olanzapine	Ascend Laboratories, LLC	ANDA	Current