FDA.reportPublic FDA data

Application 050824

Type
NDA
Sponsor
CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLINAMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLECAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050824-001OMECLAMOX-PAKAMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050824-001OMECLAMOX-PAK500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD, RS2011-02-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050824-001OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MGCAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORALRLD2011-02-08cb3db0bc1861…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66220-422Omeclamox-Pakomeprazole, clarithromycin, amoxicillinCumberland Pharmaceuticals Inc.NDACurrent
66220-422Omeclamox-Pakomeprazole, clarithromycin, amoxicillinCumberland Pharmaceuticals Inc.NDACurrent
66220-422Omeclamox-Pakomeprazole, clarithromycin, amoxicillinCumberland Pharmaceuticals Inc.NDACurrent
66220-422Omeclamox-Pakomeprazole, clarithromycin, amoxicillinCumberland Pharmaceuticals Inc.NDACurrent
66220-422Omeclamox-Pakomeprazole, clarithromycin, amoxicillinCumberland Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78386SUPPL 2024-05-03
78357SUPPL 2024-05-02
75127SUPPL 2023-08-18
75126SUPPL 2023-08-18
75103SUPPL 2023-08-17
75102SUPPL 2023-08-17
70485SUPPL2022-03-11
70430SUPPL2022-03-07
65426SUPPL2020-12-01
65366SUPPL2020-11-30
61623SUPPL2020-01-23
61618SUPPL2020-01-22
53933ORIG2018-05-01
52434APPL2018-02-06
45725SUPPL2016-10-31
45649SUPPL2016-10-26
39393SUPPL2015-01-09
8345SUPPL2014-12-31
24352ORIG2011-12-08
22252ORIG2011-12-08
8344ORIG2011-02-14
18301ORIG2011-02-09