Application 209859

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	No	No
002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 300MG BASE	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
A209859-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			2018-09-27
A209859-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL			2018-09-27

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	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209859-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2018-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209859-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL		2018-09-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209859-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209859-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209859-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209859-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209859-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209859-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209859-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209859-002	AB	1	`ea99ee380514…`

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
Ranitidine	RANITIDINE	Ajanta Pharma USA Inc.	fb67e8c7-b817-4253-a1a1-5ecdcee694cf	2021-11-24	Adverse reactions	Exact identifier application applno (ANDA): 209859 application number: ANDA209859 ndc (product): 27241-109 ndc (product): 27241-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-109	Ranitidine	Ranitidine	Ajanta Pharma Limited	ANDA	Current
27241-109	Ranitidine	Ranitidine	Ajanta Pharma Limited	ANDA	Current
27241-109	Ranitidine	Ranitidine	Ajanta Pharma USA Inc.	ANDA	Current
27241-110	Ranitidine	Ranitidine	Ajanta Pharma Limited	ANDA	Current
27241-110	Ranitidine	Ranitidine	Ajanta Pharma Limited	ANDA	Current
27241-110	Ranitidine	Ranitidine	Ajanta Pharma USA Inc.	ANDA	Current
70518-2633	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-2633	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-2633	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current