Application 210525

Type
ANDA
Sponsor
GENEYORK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL10MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL20MGNoNo
003PREDNISONEPREDNISONETABLET;ORAL50MGNoNo
004PREDNISONEPREDNISONETABLET;ORAL2.5MGNoNo
005PREDNISONEPREDNISONETABLET;ORAL5MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210525-001PREDNISONEPREDNISONE10MGTABLET / ORAL2018-12-04
A210525-002PREDNISONEPREDNISONE20MGTABLET / ORAL2018-12-04
A210525-003PREDNISONEPREDNISONE50MGTABLET / ORAL2018-12-04
A210525-004PREDNISONEPREDNISONE2.5MGTABLET / ORAL2018-12-07
A210525-005PREDNISONEPREDNISONE5MGTABLET / ORAL2018-12-07

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 5 · 163 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210525-001PREDNISONE10MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-002PREDNISONE20MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-003PREDNISONE50MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-005PREDNISONE5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-001PREDNISONE10MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-002PREDNISONE20MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-003PREDNISONE50MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-005PREDNISONE5MGTABLET / ORAL2018-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-001PREDNISONE10MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-002PREDNISONE20MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-003PREDNISONE50MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-005PREDNISONE5MGTABLET / ORAL2018-12-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210525-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210525-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210525-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210525-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210525-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210525-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210525-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210525-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210525-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210525-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210525-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210525-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210525-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210525-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210525-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210525-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210525-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210525-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210525-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210525-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210525-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210525-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210525-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210525-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210525-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A210525-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A210525-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210525-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A210525-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A210525-003AB1b00525d2431f…
2024-02-18 07:12 UTC2024-02A210525-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-004AB11c564ffb4f44…

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.19fdbf9f-3a64-b9fa-e063-6394a90af0862026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1a9f00ac-ec92-4d2c-e063-6394a90ac4f62026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.25b5958b-c151-9200-e063-6394a90af52c2026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1349a022-639b-4494-99a2-1594c7c0f0e92026-07-21Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.288ecb6d-3b0b-db95-e063-6394a90a78ff2026-07-21Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack6c0376c4-87cf-40dc-b140-a6aac75b64f72026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepackdc3bbb97-6588-46f4-b0ad-47596874ad0c2026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONEPREDNISONEAtlantic Biologicals Corps07be390e-ef1e-4bf9-a9da-4338b5f6cfa52026-07-10Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-06-24Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONEPREDNISONESt. Mary's Medical Park Pharmacy16ee689e-c7a9-3a5a-e063-6394a90a6ea22026-06-22Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-2933PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
0527-2933PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
0527-2934PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
0527-2934PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
0527-2935PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
0527-2935PREDNISONEPrednisoneLannett Company, Inc.ANDACurrent
50090-4784PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-4784PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-4785PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-5453PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-5656PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-5657PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
50090-5660PREDNISONEPrednisoneA-S Medication SolutionsANDACurrent
60760-615PREDNISONEPrednisoneSt. Mary's Medical Park PharmacyANDACurrent
60760-715PREDNISONEPrednisoneSt. Mary's Medical Park PharmacyANDACurrent
60760-715PREDNISONEPrednisoneSt. Mary's Medical Park PharmacyANDACurrent
67296-1755PREDNISONEPrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1755PREDNISONEPrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1755PREDNISONEPrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1767PREDNISONEPrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1767PREDNISONEPrednisoneRedPharm Drug, Inc.ANDACurrent
68071-2209PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2209PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2209PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2304PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2304PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5195PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5195PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5233PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5233PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5242PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5242PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5242PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5242PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5242PREDNISONEPrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7752PREDNISONEPrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7752PREDNISONEPrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7752PREDNISONEPrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8116PREDNISONEPrednisonePreferred Pharmaceuticals Inc.ANDACurrent
68788-8116PREDNISONEPrednisonePreferred Pharmaceuticals Inc.ANDACurrent
70518-2916PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70518-2916PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70518-2916PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70518-2916PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70518-3138PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70518-3138PREDNISONEPrednisoneREMEDYREPACK INC.ANDACurrent
70934-471PREDNISONEPrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-471PREDNISONEPrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-543PREDNISONEPrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-580PREDNISONEPrednisoneDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-403PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-460PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-460PREDNISONEPrednisoneProficient Rx LPANDACurrent
71205-460PREDNISONEPrednisoneProficient Rx LPANDACurrent
71329-103PREDNISONEPrednisoneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-104PREDNISONEPrednisoneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-105PREDNISONEPrednisoneGeneYork Pharmaceuticals Group LLCANDACurrent
71335-1516PREDNISONEPrednisoneBryant Ranch PrepackANDACurrent
71335-1525PREDNISONEPrednisoneBryant Ranch PrepackANDACurrent
71335-1736PREDNISONEPrednisoneBryant Ranch PrepackANDACurrent
71335-1736PREDNISONEPrednisoneBryant Ranch PrepackANDACurrent
71335-1915PREDNISONEPrednisoneBryant Ranch PrepackANDACurrent
72189-246PREDNISONEPREDNISONEDIRECT RXANDACurrent
72189-246PREDNISONEPREDNISONEDIRECT RXANDACurrent