Home Applications 075285 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 42 .
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075285-001 CIMETIDINE 200MG TABLET / ORAL 1998-10-29 caaa826d4ba7…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…
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 · 7 matching rows.
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