Application 201921

Type: ANDA
Sponsor: NATCO PHARMA 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 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
A201921-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18
A201921-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201921-001	AB
A201921-002	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 · 84 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	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A201921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201921-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201921-002	AB	1	`bb7c543d1eb4…`

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
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	136ad992-2e39-dad9-e063-6294a90adcc6	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201921 application number: ANDA201921

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-697	LANSOPRAZOLE	LANSOPRAZOLE	Rising Pharma Holdings, Inc.	ANDA	Current
16571-698	LANSOPRAZOLE	LANSOPRAZOLE	Rising Pharma Holdings, Inc.	ANDA	Current
45963-460	Lansoprazole	Lansoprazole	ACTAVIS PHARMA, INC.	ANDA	Current
45963-460	Lansoprazole	Lansoprazole	ACTAVIS PHARMA, INC.	ANDA	Current
45963-460	Lansoprazole	Lansoprazole	ACTAVIS PHARMA, INC.	ANDA	Current
50090-2225	LANSOPRAZOLE	LANSOPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-2225	LANSOPRAZOLE	LANSOPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-2739	LANSOPRAZOLE	LANSOPRAZOLE	A-S Medication Solutions	ANDA	Current
51991-771	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-771	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-771	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-772	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-772	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-772	LANSOPRAZOLE	LANSOPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
55700-393	LANSOPRAZOLE	LANSOPRAZOLE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68788-9406	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
69336-107	LANSOPRAZOLE	LANSOPRAZOLE	Sterling Knight Pharmaceuticals LLC	ANDA	Current
70934-369	LANSOPRAZOLE	LANSOPRAZOLE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-369	LANSOPRAZOLE	LANSOPRAZOLE	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current