Application 200816

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANSOPRAZOLE	LANSOPRAZOLE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	15MG	No	No
002	LANSOPRAZOLE	LANSOPRAZOLE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200816-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-27
A200816-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200816-001	AB
A200816-002	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 · 86 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	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A200816-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200816-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200816-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200816-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200816-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200816-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200816-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200816-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200816-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200816-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200816-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200816-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200816-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200816-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200816-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200816-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200816-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200816-002	AB	1	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANSOPRAZOLE	LANSOPRAZOLE	Zydus Lifesciences Limited	76ffd38e-bea8-45a0-b6bd-82f0043ce64d	2024-11-30		Exact identifier application applno (ANDA): 200816 application number: ANDA200816 ndc (product): 70771-1132 ndc (product): 70771-1133
LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc.	9b3869ad-f2f7-4954-b75c-5c23b8951635	2022-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200816 application number: ANDA200816 ndc (product): 68382-772 ndc (product): 68382-771

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
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-771	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-772	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1132	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Lifesciences Limited	ANDA	Current
70771-1132	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current
70771-1132	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current
70771-1132	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current
70771-1133	LANSOPRAZOLE	LANSOPRAZOLE	Zydus Lifesciences Limited	ANDA	Current
70771-1133	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current
70771-1133	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current
70771-1133	LANSOPRAZOLE	LANSOPRAZOLE	Cadila Healthcare Limited	ANDA	Current