Application 075285

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIMETIDINE	CIMETIDINE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075285-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL			1998-10-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACID CONTROLLER	CIMETIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	cf772ee0-680a-4e1c-8c5d-929756896b36	2026-05-11	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285
heartburn prevention	CIMETIDINE	H E B	f7156440-f2d8-4292-a436-388622ff3965	2025-08-26	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 59640-022
cimetidine 200 acid reducer	CIMETIDINE	Walgreen Company	7087f4bb-992b-4680-a9a7-452ce74eed2d	2025-03-10	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 0363-0022
Equate Cimetidine	CIMETIDINE	Wal-Mart Stores Inc	ad3e8f6a-8e35-42c2-a98c-566a2868e923	2022-03-10	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 49035-820
basic care acid reducer	CIMETIDINE	Amazon.com Services LLC	ffba8756-b9de-4d18-85fa-b4dd25d2cb4c	2022-01-14	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 72288-022
heartburn relief	CIMETIDINE	CVS Pharmacy	464b1dec-3220-471c-b067-a06a87fb8cae	2022-01-05	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 59779-022

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0022	Good Sense Heartburn Relief	Cimetidine	L. Perrigo Company	ANDA	Current
0113-0022	Good Sense Heartburn Relief	Cimetidine	L. Perrigo Company	ANDA	Current
0113-0022	Good Sense Heartburn Relief	Cimetidine	L. Perrigo Company	ANDA	Current
0363-0022	cimetidine	Cimetidine	Walgreen Company	ANDA	Current
0363-0022	cimetidine	Cimetidine	Walgreen Company	ANDA	Current
0363-0022	cimetidine	Cimetidine	Walgreen Company	ANDA	Current
0363-0022	cimetidine	Cimetidine	Walgreen Company	ANDA	Current
24385-111	Good Neighbor Pharmacy Heartburn Relief	Cimetidine	Amerisource Bergen	ANDA	Current
24385-111	Good Neighbor Pharmacy Heartburn Relief	Cimetidine	Amerisource Bergen	ANDA	Current
24385-111	Good Neighbor Pharmacy Heartburn Relief	Cimetidine	Amerisource Bergen	ANDA	Current
30142-323	Acid Reducer	Cimetidine	Kroger Company	ANDA	Current
30142-323	Acid Reducer	Cimetidine	Kroger Company	ANDA	Current
30142-323	Acid Reducer	Cimetidine	Kroger Company	ANDA	Current
36800-022	TopCare Heartburn Relief	Cimetidine	Topco Associates LLC	ANDA	Current
36800-022	TopCare Heartburn Relief	Cimetidine	Topco Associates LLC	ANDA	Current
36800-022	TopCare Heartburn Relief	Cimetidine	Topco Associates LLC	ANDA	Current
36800-022	TopCare Heartburn Relief	Cimetidine	Topco Associates LLC	ANDA	Current
49035-820	Equate Cimetidine	Cimetidine	Wal-Mart Stores Inc	ANDA	Current
49035-820	Equate Cimetidine	Cimetidine	Wal-Mart Stores Inc	ANDA	Current
49035-820	Equate Cimetidine	Cimetidine	Wal-Mart Stores Inc	ANDA	Current
49035-820	Equate Cimetidine	Cimetidine	Wal-Mart Stores Inc	ANDA	Current
49035-820	Equate Cimetidine	Cimetidine	Wal-Mart Stores Inc	ANDA	Current
49348-246	SunMark heartburn relief	Cimetidine	Strategic Sourcing Services LLC	ANDA	Current
49348-246	SunMark heartburn relief	Cimetidine	Strategic Sourcing Services LLC	ANDA	Current
49348-246	SunMark heartburn relief	Cimetidine	McKesson	ANDA	Current
59640-022	heartburn prevention	Cimetidine	H E B	ANDA	Current
59779-022	heartburn relief	Cimetidine	CVS Pharmacy	ANDA	Current
59779-022	heartburn relief	Cimetidine	CVS Pharmacy	ANDA	Current
59779-022	heartburn relief	Cimetidine	CVS Pharmacy	ANDA	Current
59779-022	heartburn relief	Cimetidine	CVS Pharmacy	ANDA	Current
59779-022	heartburn relief	Cimetidine	CVS Pharmacy	ANDA	Current
63629-4203	Good Sense Heartburn Relief	Cimetidine	Bryant Ranch Prepack	ANDA	Current
69256-022	harris teeter acid reducer	Cimetidine	Harris Teeter, LLC	ANDA	Current
69256-022	harris teeter acid reducer	Cimetidine	Harris Teeter, LLC	ANDA	Current
69256-022	harris teeter acid reducer	Cimetidine	Harris Teeter, LLC	ANDA	Current
72288-022	basic care acid reducer	Cimetidine	Amazon.com Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22454	ORIG	1998-10-29
8598	ORIG	1998-10-29