FDA.reportPublic FDA data

Application 080356

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL5MGNoNo

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
A080356-001PREDNISONEPREDNISONE5MGTABLET / 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
A080356-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A080356-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A080356-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080356-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080356-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080356-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080356-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080356-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080356-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080356-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080356-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080356-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080356-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080356-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080356-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080356-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080356-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080356-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080356-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080356-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080356-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080356-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080356-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080356-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A080356-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080356-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080356-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080356-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A080356-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080356-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080356-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080356-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080356-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080356-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080356-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080356-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080356-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080356-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080356-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080356-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080356-001AB1f41ea6bd6efb…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEREMEDYREPACK INC.4bd86b2f-75cb-4711-85e2-b81ed947cb132026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
ndc (product): 70518-3537
PrednisonePREDNISONEQPharma, Inc.f4d5974a-444f-4ef0-84a9-803150ccdeac2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
ndc (product): 42708-114
PrednisonePREDNISONEActavis Pharma, Inc.aa0b1582-6ef3-4697-9ea6-5391e6e578532024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
ndc (product): 0591-5052
PrednisonePREDNISONEPharmPak, Inc.03aaf69f-d9c7-433c-baea-9c6eca0fe1e52022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
ndc (product): 54348-506
PrednisonePREDNISONEProficient Rx LPa1bff575-cd79-4596-99f1-30a5fe8a8b4c2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
ndc (product): 63187-997

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 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-8165PrednisonePrednisoneLiberty Pharmaceuticals, Inc.ANDACurrent
0591-5052PrednisonePrednisoneActavis Pharma, Inc.ANDACurrent
0591-5052PrednisonePrednisoneActavis Pharma, Inc.ANDACurrent
42708-114PrednisonePrednisoneQPharma IncANDACurrent
42708-114PrednisonePrednisoneQPharma IncANDACurrent
42708-114PrednisonePrednisoneQPharma IncANDACurrent
42708-114PrednisonePrednisoneQPharma IncANDACurrent
43353-819PrednisonePrednisoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3273PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3273PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3273PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3273PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3273PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-3310PrednisonePrednisoneA-S Medication SolutionsANDACurrent
53002-3520PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-3520PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
54348-506PrednisonePREDNISONEPharmPak, Inc.ANDACurrent
54348-506PrednisonePREDNISONEPharmPak, Inc.ANDACurrent
61919-108PREDNISONEPREDNISONEDIRECT RXANDACurrent
61919-108PREDNISONEPREDNISONEDIRECT RXANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
61919-326PREDNISONEPREDNISONEDirect_RxANDACurrent
63187-997PrednisonePrednisoneProficient Rx LPANDACurrent
63187-997PrednisonePrednisoneProficient Rx LPANDACurrent
63187-997PrednisonePrednisoneProficient Rx LPANDACurrent
63187-997PrednisonePrednisoneProficient Rx LPANDACurrent
63187-997PrednisonePrednisoneProficient Rx LPANDACurrent
63629-7753PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-7753PrednisonePrednisoneBryant Ranch PrepackANDACurrent
66267-948PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1203PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1203PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
67296-1203PrednisonePrednisoneRedPharm Drug, Inc.ANDACurrent
68071-2445PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2594PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4546PrednisonePrednisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7281PrednisonePrednisonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7281PrednisonePrednisonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7281PrednisonePrednisonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7692PrednisonePrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7692PrednisonePrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7692PrednisonePrednisonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-3537PrednisonePrednisoneREMEDYREPACK INC.ANDACurrent
71335-0856PrednisonePrednisoneBryant Ranch PrepackANDACurrent
71335-0856PrednisonePrednisoneBryant Ranch PrepackANDACurrent