Application 207394

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	No	No
002	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207394-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-01-18
A207394-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207394-001	AB
A207394-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207394-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207394-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-01-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207394-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207394-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207394-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207394-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207394-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207394-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207394-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207394-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207394-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207394-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207394-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207394-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207394-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207394-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207394-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207394-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207394-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207394-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207394-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207394-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207394-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207394-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207394-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207394-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207394-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207394-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207394-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207394-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207394-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207394-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207394-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207394-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207394-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207394-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207394-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207394-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207394-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207394-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207394-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207394-002	AB	1	`782e0a99824c…`

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
Lansoprazole	LANSOPRAZOLE	Asclemed USA, Inc.	71be1129-8562-476e-9d9b-99a21cbf52ec	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207394 application number: ANDA207394
Lansoprazole	LANSOPRAZOLE	Medcore LLC	18b4020f-d7e6-42f8-838d-2b5da152530e	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207394 application number: ANDA207394
Lansoprazole	LANSOPRAZOLE	Ascend Laboratories, LLC	9e246e79-2737-4cbb-ad5d-4e76893da3be	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207394 application number: ANDA207394 ndc (product): 67877-275 ndc (product): 67877-274
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	8bbc3af5-faa1-4af1-94e9-9df4aae242ab	2023-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207394 application number: ANDA207394 ndc (product): 50090-5180

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5180	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
50090-5180	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
67877-274	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current
67877-274	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current
67877-274	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current
67877-275	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current
67877-275	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current
67877-275	Lansoprazole	Lansoprazole	Ascend Laboratories, LLC	ANDA	Current