Application 050797

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZMAXAZITHROMYCINFOR SUSPENSION, EXTENDED RELEASE;ORALEQ 2GM BASE/BOTYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050797-001ZMAXAZITHROMYCINEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1084e616aacf4f…
2026-08-18 06:07:402026-07N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050797-001ZMAXEQ 2GM BASE/BOTFOR SUSPENSION, EXTENDED RELEASE / ORALRLD2005-06-10f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050797-00169844032024-02-14U-282Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050797-00178878442024-02-14Drug product2011-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050797-00169844032024-02-14U-282Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050797-00178878442024-02-14Drug product2011-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050797-00169844032024-02-14U-282Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050797-00178878442024-02-14Drug product2011-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050797-00169844032024-02-14U-282Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050797-00178878442024-02-14Drug product2011-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050797-00169844032024-02-14U-282Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N050797-00178878442024-02-14Drug product2011-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050797-00169844032024-02-14U-282Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050797-00178878442024-02-14Drug product2011-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050797-00169844032024-02-14U-282Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050797-00178878442024-02-14Drug product2011-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050797-00169844032024-02-14U-282Drug product1e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050797-00178878442024-02-14Drug product2011-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050797-00169844032024-02-14U-282Drug product8072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050797-00178878442024-02-14Drug product2011-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050797-00169844032024-02-14U-282Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050797-00178878442024-02-14Drug product2011-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050797-00169844032024-02-14U-282Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050797-00178878442024-02-14Drug product2011-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050797-00169844032024-02-14U-282Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050797-00178878442024-02-14Drug product2011-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050797-00169844032024-02-14U-282Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050797-00178878442024-02-14Drug product2011-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050797-00169844032024-02-14U-282Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050797-00178878442024-02-14Drug product2011-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050797-00169844032024-02-14U-282Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N050797-00178878442024-02-14Drug product2011-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050797-00169844032024-02-14U-282Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050797-00178878442024-02-14Drug product2011-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N050797-00169844032024-02-14U-282Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050797-00178878442024-02-14Drug product2011-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050797-00169844032024-02-14U-282Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050797-00178878442024-02-14Drug product2011-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050797-00169844032024-02-14U-282Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N050797-00178878442024-02-14Drug product2011-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050797-00169844032024-02-14U-282Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N050797-00178878442024-02-14Drug product2011-03-153f01610625f2…

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 4 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINAdvanced Rx Pharmacy of Tennessee, LLCf175496a-4ad3-ce0d-e053-2a95a90a66132024-12-31Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAsclemed USA, Inc.22a4d2b3-daea-4d96-891f-4b98236294562024-10-04Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP90605f94-93e1-43d1-8be7-830e816ac84f2024-10-01Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP38942011-f86b-4e42-a4ca-05a70d9dd3d92024-10-01Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b0138503-ddc4-2e1c-e053-2995a90a0d2d2024-07-17Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b43d23c7-1a2e-ce93-e053-2995a90a65a42024-07-17Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.9270e676-3382-6483-e053-2a95a90a556e2024-06-19Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.8e7184e1-3c3c-cd87-e053-2a95a90a6eb62024-06-18Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.826f9c07-8eb9-a128-e053-2991aa0ad6542024-06-14Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.896cce83-23ac-f4ed-e053-2a95a90ad1072024-06-14Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions4278e306-bc26-4282-93ce-f1405e0b5d4a2024-06-12Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINChartwell RX, LLC2c9de2e9-c20c-4660-a272-a22019f9fb022024-04-09Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP44134421-cb0b-4e85-a3c8-d58bdb476fad2024-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF2b821631-0df2-0fb2-e054-00144ff8d46c2024-02-29Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAsclemed USA, Inc.b77b347d-d357-4bdf-b985-49d9a1dd634c2023-12-30Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-444ZmaxazithromycinRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69396SUPPL2021-11-23
69387SUPPL2021-11-23
58416SUPPL2019-04-25
58405SUPPL2019-04-24
47840SUPPL2017-04-03
47795SUPPL2017-03-31
47186SUPPL2017-02-13
47170SUPPL2017-02-10
8318SUPPL2016-05-26
39363SUPPL2016-05-25
8317SUPPL2015-07-10
39362SUPPL2015-07-06
39360SUPPL2013-10-17
30585SUPPL2013-10-15
44210ORIG2013-03-12
30588SUPPL2013-02-21
18283SUPPL2013-02-21
18282SUPPL2012-03-06
30587SUPPL2012-03-05
39361SUPPL2011-09-20
18281SUPPL2011-09-20
18280SUPPL2011-09-20
30586SUPPL2011-06-10
30584SUPPL2011-06-10
8316SUPPL2011-06-10
18279SUPPL2008-10-09
8315SUPPL2008-10-09
8314SUPPL2007-11-08
39359SUPPL2007-11-07
42744ORIG2007-09-10
30583ORIG2005-06-14
18278ORIG2005-06-14
53182SUPPL1900-01-01
53181SUPPL1900-01-01