Application 020238

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAGAMET HB	CIMETIDINE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	TAGAMET HB	CIMETIDINE	TABLET;ORAL	200MG	Yes	Yes

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

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
N020238-001	TAGAMET HB	CIMETIDINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-06-19
N020238-002	TAGAMET HB	CIMETIDINE	200MG	TABLET / ORAL		RLD, RS	1996-08-21

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 3 · 88 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UTC	2019-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1995-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020238-001	TAGAMET HB	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020238-002	TAGAMET HB	200MG	TABLET / ORAL	RLD, RS	1996-08-21	`3a93d1ddd44b…`

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
Tagamet	CIMETIDINE	Medtech Products Inc.	e6401e0a-8612-42e8-bf89-2d67243f28dc	2024-06-10	Warnings	Exact identifier application applno (NDA): 020238 application number: NDA020238 ndc (product): 63029-222
TAGAMET	CIMETIDINE	Prestige Brands Holdings, Inc.	c8ba8815-9d99-439f-b397-3869f729d9f4	2023-01-20	Warnings	Exact identifier application applno (NDA): 020238 application number: NDA020238

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63029-222	Tagamet	Cimetidine	Medtech Products Inc.	NDA	Current
63029-222	Tagamet	Cimetidine	Medtech Products Inc.	NDA	Current
63029-222	Tagamet	Cimetidine	Medtech Products Inc.	NDA	Current
63029-222	Tagamet	Cimetidine	Medtech Products Inc.	NDA	Current
63029-222	Tagamet	Cimetidine	Medtech Products Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71187	SUPPL	2022-06-01
71147	SUPPL	2022-05-25
67993	SUPPL	2021-06-30
67914	SUPPL	2021-06-28
62562	SUPPL	2020-04-14
62561	SUPPL	2020-04-14
58096	SUPPL	2019-03-27
58093	SUPPL	2019-03-27
20548	SUPPL	2008-07-30
2225	SUPPL	2008-02-13
24633	SUPPL	2006-10-05
12352	SUPPL	2005-05-17
2224	SUPPL	2005-05-17