FDA.reportPublic FDA data

Application 085161

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A085161-001PREDNISONEPREDNISONE20MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A085161-001AB

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A085161-001PREDNISONE20MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085161-001PREDNISONE20MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085161-001PREDNISONE20MGTABLET / ORALABApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085161-001PREDNISONE20MGTABLET / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A085161-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A085161-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A085161-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085161-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085161-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085161-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085161-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085161-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085161-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085161-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085161-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085161-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085161-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085161-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085161-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085161-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085161-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085161-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085161-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085161-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085161-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085161-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085161-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085161-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085161-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085161-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085161-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085161-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085161-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085161-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085161-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085161-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085161-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085161-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085161-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085161-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085161-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085161-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085161-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085161-001AB13a93d1ddd44b…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEA-S Medication Solutionsaaaa3460-0239-4203-857f-0ada303c21082026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 50090-2789
PrednisonePREDNISONEA-S Medication Solutionsa6811c1f-3dad-46bb-b541-fddd2ff8e5692026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 50090-2786
PrednisonePREDNISONENorthwind Health Company, LLCf6cb7924-4190-f130-e053-6294a90a21fe2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
PrednisonePREDNISONEQPharma, Inc.d898d53f-c7d2-4bdb-bd9e-5f200070d1232025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 42708-105
PrednisonePREDNISONEActavis Pharma, Inc.aa0b1582-6ef3-4697-9ea6-5391e6e578532024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 0591-5443
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.7e541478-4a33-189f-e053-2a91aa0a69622024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 68071-4685
PrednisonePREDNISONEProficient Rx LP016d65c3-fff2-4e0c-9025-e2083cfa6a1f2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085161
application number: ANDA085161
ndc (product): 71205-239

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 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5443PrednisonePrednisoneActavis Pharma, Inc.ANDACurrent
0591-5443PrednisonePrednisoneActavis Pharma, Inc.ANDACurrent
10544-045PrednisonePrednisoneBlenheim Pharmacal, Inc.ANDACurrent
42708-105PrednisonePrednisoneQPharma IncANDACurrent
42708-105PrednisonePrednisoneQPharma IncANDACurrent
42708-105PrednisonePrednisoneQPharma IncANDACurrent
42708-105PrednisonePrednisoneQPharma IncANDACurrent
50090-2786PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-2789PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-2789PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-2789PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-2804PrednisonePrednisoneA-S Medication SolutionsANDACurrent
53002-3252PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
55154-8130PrednisonePrednisoneCardinal HealthANDACurrent
55154-8130PrednisonePrednisoneCardinal HealthANDACurrent
55700-728PrednisonePrednisoneQuality Care Products, LLCANDACurrent
55700-728PrednisonePrednisoneQuality Care Products, LLCANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDiect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
63739-588PrednisonePrednisoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-588PrednisonePrednisoneMcKesson Corporation dba SKY PackagingANDACurrent
63739-588PrednisonePrednisoneMcKesson Corporation dba SKY PackagingANDACurrent
67296-0138PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-0138PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-0138PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-0138PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
68071-4685PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4685PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,InANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4691PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7637PrednisonePrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7637PrednisonePrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1561PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1854PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1854PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1854PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-1854PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2073PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2314PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2314PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2314PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2314PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70518-2314PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
70934-218PrednisonePrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-218PrednisonePrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-218PrednisonePrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-218PrednisonePrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-674PrednisonePrednisoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-239PrednisonePrednisoneProficient Rx LPANDACurrent
71205-239PrednisonePrednisoneProficient Rx LPANDACurrent
71205-239PrednisonePrednisoneProficient Rx LPANDACurrent
71205-239PrednisonePrednisoneProficient Rx LPANDACurrent
71335-0857PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-0857PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-1285PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-1285PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-1285PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-1294PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-1629PrednisonePrednisoneBryant Ranch PrepackANDACurrent