Application 020251

Type: NDA
Sponsor: GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZANTAC 150	RANITIDINE HYDROCHLORIDE	TABLET, EFFERVESCENT;ORAL	EQ 150MG BASE	No	No
002	ZANTAC 150	RANITIDINE HYDROCHLORIDE	GRANULE, EFFERVESCENT;ORAL	EQ 150MG BASE/PACKET	No	No
003	ZANTAC 25	RANITIDINE HYDROCHLORIDE	TABLET, EFFERVESCENT;ORAL	EQ 25MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020251-001	ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31
N020251-002	ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31
N020251-003	ZANTAC 25	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020251-003	ZANTAC 25	EQ 25MG BASE	TABLET, EFFERVESCENT / ORAL	2004-04-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020251-001	ZANTAC 150	EQ 150MG BASE	TABLET, EFFERVESCENT / ORAL	1994-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020251-002	ZANTAC 150	EQ 150MG BASE/PACKET	GRANULE, EFFERVESCENT / ORAL	1994-03-31	`c0c555d07b60…`

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 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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24662	SUPPL	2009-11-12
12375	SUPPL	2009-10-06
34434	SUPPL	2009-03-27
2249	SUPPL	2009-02-19
2248	SUPPL	2006-07-21
34433	SUPPL	2005-05-02
2247	SUPPL	2005-05-02
24660	SUPPL	2004-07-01
34432	SUPPL	2004-05-03
2246	SUPPL	2004-04-07
20557	SUPPL	2003-04-29
24661	SUPPL	2002-01-07