Application 207578

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207578-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2017-11-13

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207578-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2017-11-13	`e64feba35796…`

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10202-712	MAXIMUM STRENGTH RANITIDINE	Ranitidine	7-Eleven	ANDA	Current
10202-712	MAXIMUM STRENGTH RANITIDINE	Ranitidine	7-Eleven	ANDA	Current
10202-712	MAXIMUM STRENGTH RANITIDINE	Ranitidine	7-Eleven	ANDA	Current
53943-018	MAXIMUM STRENGTH RANITIDINE	Ranitidine	DISCOUNT DRUG MART	ANDA	Current
53943-018	MAXIMUM STRENGTH RANITIDINE	Ranitidine	DISCOUNT DRUG MART	ANDA	Current
55910-092	ACID REDUCER	Ranitidine	Dolgencorp, LLC	ANDA	Current
55910-092	ACID REDUCER	Ranitidine	Dolgencorp, LLC	ANDA	Current
57243-280	MAXIMUM STRENGTH RANITIDINE	Ranitidine	McLane Company, Inc.	ANDA	Current
57243-280	MAXIMUM STRENGTH RANITIDINE	Ranitidine	McLane Company, Inc.	ANDA	Current
58602-734	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Aurohealth LLC	ANDA	Current
58602-734	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Aurohealth LLC	ANDA	Current
58602-734	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Aurohealth LLC	ANDA	Current
58602-734	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Aurohealth LLC	ANDA	Current
58602-734	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Aurohealth LLC	ANDA	Current
58602-740	Maximum Strength Ranitidine	Ranitidine	Aurohealth LLC	ANDA	Current
58602-740	Maximum Strength Ranitidine	Ranitidine	Aurohealth LLC	ANDA	Current
58602-740	Maximum Strength Ranitidine	Ranitidine	Aurohealth LLC	ANDA	Current
58602-740	Maximum Strength Ranitidine	Ranitidine	Aurohealth LLC	ANDA	Current
58602-740	Maximum Strength Ranitidine	Ranitidine	Aurohealth LLC	ANDA	Current
67091-317	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Winco Foods, LLC.	ANDA	Current
67091-317	MAXIMUM STRENGTH RANITIDINE	Ranitidine	Winco Foods, LLC.	ANDA	Current