Application 205512

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	No	No
002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 300MG BASE	No	Yes

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
A205512-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2016-08-22
A205512-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2016-08-22

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	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2016-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2016-08-22	`74a2ff9319b5…`

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	A205512-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205512-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205512-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205512-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205512-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205512-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205512-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205512-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranitidine Hydrochloride	RANITIDINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	7bf94bf7-fa11-70be-9f65-fe26a3db5a63	2018-11-21	Adverse reactions	Name fallback brand name: Ranitidine Hydrochloride generic name: RANITIDINE HYDROCHLORIDE
Acid Reducer	RANITIDINE HYDROCHLORIDE	WinCo Foods, LLC	70bc7062-ab3c-43eb-b524-0d8c6d1a674d	2014-12-10	Warnings	Name fallback generic name: RANITIDINE HYDROCHLORIDE

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 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-244	Ranitidine	Ranitidine	Golden State Medical Supply Inc.	ANDA	Current
51407-244	Ranitidine	Ranitidine	Golden State Medical Supply, Inc.	ANDA	Current
51407-245	Ranitidine	Ranitidine	Golden State Medical Supply Inc.	ANDA	Current
51407-245	Ranitidine	Ranitidine	Golden State Medical Supply, Inc.	ANDA	Current
53002-1028	Ranitidine	Ranitidine	RPK Pharmaceuticals, Inc.	ANDA	Current
58118-0803	Ranitidine	Ranitidine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0803	Ranitidine	Ranitidine	Clinical Solutions Wholesale, LLC	ANDA	Current
63187-855	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
63187-855	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
64380-803	Ranitidine	Ranitidine	Strides Shasun Limited	ANDA	Current
64380-803	Ranitidine	Ranitidine	Strides Pharma Science Limited	ANDA	Current
64380-804	Ranitidine	Ranitidine	Strides Shasun Limited	ANDA	Current
64380-804	Ranitidine	Ranitidine	Strides Pharma Science Limited	ANDA	Current
64380-936	Ranitidine	Ranitidine	Strides Pharma Science Limited	ANDA	Current
64380-937	Ranitidine	Ranitidine	Strides Pharma Science Limited	ANDA	Current
68788-7423	Ranitidine	Ranitidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0004	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-0004	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-0004	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-0017	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-0017	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-0017	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-1043	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-1043	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-1952	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70518-1952	Ranitidine	Ranitidine	REMEDYREPACK INC.	ANDA	Current
70934-332	Ranitidine	Ranitidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-007	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
71205-007	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
71335-0042	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
71335-0042	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
71610-359	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-371	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-378	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current