Application 017939

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TAGAMET	CIMETIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017939-002	TAGAMET	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017939-002	TAGAMET	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017939-002	TAGAMET	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017939-002	TAGAMET	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017939-002	TAGAMET	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	Chartwell RX, LLC	d1d73350-4e7e-428a-90a5-6000fd373a4f	2026-02-05	Adverse reactions	Name fallback generic name: CIMETIDINE HYDROCHLORIDE
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	e40bb1f6-338a-42e7-9217-8c32d14ccfd3	2025-11-04	Adverse reactions	Name fallback generic name: CIMETIDINE HYDROCHLORIDE
Cimetidine Hydrochloride	CIMETIDINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	b8b50bd9-bc1b-4da5-96c5-8eb917c8937f	2025-01-06	Adverse reactions	Name fallback generic name: CIMETIDINE HYDROCHLORIDE
Tagamet	CIMETIDINE	Medtech Products Inc.	e6401e0a-8612-42e8-bf89-2d67243f28dc	2024-06-10	Warnings	Name fallback brand name: Tagamet
TAGAMET	CIMETIDINE	Prestige Brands Holdings, Inc.	c8ba8815-9d99-439f-b397-3869f729d9f4	2023-01-20	Warnings	Name fallback brand name: TAGAMET

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.