Application 017920

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TAGAMET	CIMETIDINE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	TAGAMET	CIMETIDINE	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	TAGAMET	CIMETIDINE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	TAGAMET	CIMETIDINE	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017920-002	TAGAMET	CIMETIDINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017920-003	TAGAMET	CIMETIDINE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017920-004	TAGAMET	CIMETIDINE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1983-12-14
N017920-005	TAGAMET	CIMETIDINE	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-04-30

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1983-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1983-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1986-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017920-002	TAGAMET	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017920-003	TAGAMET	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017920-004	TAGAMET	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1983-12-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017920-005	TAGAMET	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		1986-04-30	`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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer	CIMETIDINE	Amazon.com Services LLC	81dbc581-aa51-46bf-8b69-6d926de2f583	2026-08-18	Warnings	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	Mylan Pharmaceuticals Inc.	06c0a509-026f-44e0-9975-a94a8de51d43	2026-07-15	Adverse reactions	Name fallback generic name: CIMETIDINE
ACID CONTROLLER	CIMETIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	cf772ee0-680a-4e1c-8c5d-929756896b36	2026-05-11	Warnings	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	Bryant Ranch Prepack	0ab5ea2b-bd2f-49ec-9e92-033bed998797	2026-03-09	Adverse reactions	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	Northwind Health Company, LLC	db482bd8-e68d-3a38-e053-2995a90a38a5	2026-01-01	Adverse reactions	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	PD-Rx Pharmaceuticals, Inc.	28fd7158-a617-436a-8f5c-71ffbaafe527	2025-10-20	Adverse reactions	Name fallback generic name: CIMETIDINE
heartburn prevention	CIMETIDINE	H E B	f7156440-f2d8-4292-a436-388622ff3965	2025-08-26	Warnings	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	A-S Medication Solutions	28fa98b3-6c78-4b7b-9a37-84c879dbf58a	2025-05-02	Adverse reactions	Name fallback generic name: CIMETIDINE
cimetidine 200 acid reducer	CIMETIDINE	Walgreen Company	7087f4bb-992b-4680-a9a7-452ce74eed2d	2025-03-10	Warnings	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	Bionpharma Inc.	2d7b6e7d-cf01-70a2-e063-6394a90afbe6	2025-02-20	Adverse reactions	Name fallback generic name: CIMETIDINE
CIMETIDINE	CIMETIDINE	Aurobindo Pharma Limited	ebd53065-c080-4045-a398-64d3f3b1460f	2024-11-14	Adverse reactions	Name fallback generic name: CIMETIDINE
Cimetidine	CIMETIDINE	A-S Medication Solutions	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	2024-11-08	Adverse reactions	Name fallback generic name: CIMETIDINE
Tagamet	CIMETIDINE	Medtech Products Inc.	e6401e0a-8612-42e8-bf89-2d67243f28dc	2024-06-10	Warnings	Name fallback brand name: Tagamet generic name: CIMETIDINE
Cimetidine	CIMETIDINE	Proficient Rx LP	5c2e1f52-4021-4f70-9b2b-63af17094187	2024-04-01	Adverse reactions	Name fallback generic name: CIMETIDINE
CIMETIDINE	CIMETIDINE	Chartwell RX, LLC	01997826-7ca1-473e-bfc9-075b14b58a35	2023-08-18	Adverse reactions	Name fallback generic name: CIMETIDINE
TAGAMET	CIMETIDINE	Prestige Brands Holdings, Inc.	c8ba8815-9d99-439f-b397-3869f729d9f4	2023-01-20	Warnings	Name fallback brand name: TAGAMET generic name: CIMETIDINE
Equate Cimetidine	CIMETIDINE	Wal-Mart Stores Inc	ad3e8f6a-8e35-42c2-a98c-566a2868e923	2022-03-10	Warnings	Name fallback generic name: CIMETIDINE
basic care acid reducer	CIMETIDINE	Amazon.com Services LLC	ffba8756-b9de-4d18-85fa-b4dd25d2cb4c	2022-01-14	Warnings	Name fallback generic name: CIMETIDINE
heartburn relief	CIMETIDINE	CVS Pharmacy	464b1dec-3220-471c-b067-a06a87fb8cae	2022-01-05	Warnings	Name fallback generic name: CIMETIDINE

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
747	SUPPL	2006-07-21
13953	SUPPL	2005-12-16