Application 202294

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	60MG	No	No
002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202294-001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2017-04-19
A202294-002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202294-001	AB
A202294-002	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 2 · 71 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	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A202294-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202294-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202294-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202294-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202294-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202294-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202294-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202294-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202294-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202294-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202294-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202294-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202294-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202294-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202294-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202294-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202294-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202294-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202294-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202294-001	AB	1	`c0c555d07b60…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexlansoprazole	DEXLANSOPRAZOLE	Par Health USA, LLC	d7452a26-db20-42fc-868a-a3e3606ca895	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294 ndc (product): 49884-148
Dexlansoprazole	DEXLANSOPRAZOLE	A-S Medication Solutions	fc3de800-bfad-4e2f-b664-d58a67550b2f	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294
Dexlansoprazole	DEXLANSOPRAZOLE	Bryant Ranch Prepack	caad4ada-2cf9-4e12-99df-6ca4388cf0f6	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294
Dexlansoprazole	DEXLANSOPRAZOLE	Bryant Ranch Prepack	3ed69e5a-aa78-4118-aa32-59a10f80c901	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-148	Dexlansoprazole	Dexlansoprazole	Par Pharmaceutical, Inc.	ANDA	Current
49884-148	Dexlansoprazole	Dexlansoprazole	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48170	ORIG	2017-05-01
48079	ORIG	2017-04-21
62968	ORIG	1900-01-01
62967	ORIG	1900-01-01
62966	ORIG	1900-01-01
62965	ORIG	1900-01-01