Application 071450

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLOPURINOLALLOPURINOLTABLET;ORAL300MGNoNo
002ALLOPURINOLALLOPURINOLTABLET;ORAL100MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071450-001ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB1987-01-09
A071450-002ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB1987-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A071450-001AB
A071450-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071450-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071450-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071450-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071450-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071450-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071450-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071450-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071450-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071450-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071450-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071450-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071450-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071450-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071450-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071450-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071450-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071450-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A071450-002AB1782e0a99824c…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLSun Pharmaceutical Industries, Inc.fd8f8b8b-f25e-46e9-969a-65363b66e09b2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 53489-156
ndc (product): 53489-157
AllopurinolALLOPURINOLBryant Ranch Prepack156d743c-6324-44db-9230-21f762d64cfd2026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.b2ab2389-ccaf-487b-9985-50e3539e76172026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 43063-975
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.211e47c6-85b9-43e8-9e07-6cc4b8f708a02026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 43063-976
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f1c11f74-1de2-484c-b40b-d0013e8fd01a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 43063-934
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f130c9c0-45d8-42bc-a040-04bb077671f82026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 43063-935
AllopurinolALLOPURINOLNorthwind Health Company, LLCdf745f5f-7f05-205d-e053-2995a90a05a42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 51655-968
AllopurinolALLOPURINOLNorthwind Health Company, LLCf67d4aa7-6e5f-bba1-e053-2a95a90a11942025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLProficient Rx LPb20c6ed4-6b94-4a1b-b448-e910856fa8252022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 71205-377
AllopurinolALLOPURINOLProficient Rx LP06cf0f4b-aef0-472e-b5c0-56e0c35354f22022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 71205-208
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLCbb8f09b6-c9f5-4deb-81e1-8d743e6221262019-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 71610-253
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC3f5905f1-243e-4880-ad1c-d34064f173562019-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 71610-197

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-934AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-935AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-975AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-976AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-976AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-976AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-976AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-976AllopurinolAllopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3758AllopurinolAllopurinolA-S Medication SolutionsANDACurrent
50090-3758AllopurinolAllopurinolA-S Medication SolutionsANDACurrent
50090-3758AllopurinolAllopurinolA-S Medication SolutionsANDACurrent
50090-3760AllopurinolAllopurinolA-S Medication SolutionsANDACurrent
50090-3760AllopurinolAllopurinolA-S Medication SolutionsANDACurrent
51655-968AllopurinolAllopurinolNorthwind PharmaceuticalsANDACurrent
53002-4820AllopurinolAllopurinolRPK Pharmaceuticals, Inc.ANDACurrent
53002-4820AllopurinolAllopurinolRPK Pharmaceuticals, Inc.ANDACurrent
53489-156AllopurinolAllopurinolSun Pharmaceutical Industries, Inc.ANDACurrent
53489-157AllopurinolAllopurinolSun Pharmaceutical Industries, Inc.ANDACurrent
58118-1156AllopurinolAllopurinolClinical Solutions Wholesale, LLCANDACurrent
58118-1156AllopurinolAllopurinolClinical Solutions Wholesale, LLCANDACurrent
58118-1156AllopurinolAllopurinolClinical Solutions Wholesale, LLCANDACurrent
67046-022AllopurinolAllopurinolContract Pharmacy Services-PAANDACurrent
70518-1576AllopurinolAllopurinolREMEDYREPACK INC.ANDACurrent
70518-1576AllopurinolAllopurinolREMEDYREPACK INC.ANDACurrent
70518-3289AllopurinolAllopurinolREMEDYREPACK INC.ANDACurrent
70934-209AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-209AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-295AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-295AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-389AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-389AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-389AllopurinolAllopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-681AllopurinolAllopurinolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-681AllopurinolAllopurinolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-681AllopurinolAllopurinolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-208AllopurinolAllopurinolProficient Rx LPANDACurrent
71205-208AllopurinolAllopurinolProficient Rx LPANDACurrent
71205-208AllopurinolAllopurinolProficient Rx LPANDACurrent
71205-377AllopurinolAllopurinolProficient Rx LPANDACurrent
71205-377AllopurinolAllopurinolProficient Rx LPANDACurrent
71205-377AllopurinolAllopurinolProficient Rx LPANDACurrent
71335-0599AllopurinolAllopurinolBryant Ranch PrepackANDACurrent
71610-197AllopurinolAllopurinolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-253AllopurinolAllopurinolAphena Pharma Solutions - Tennessee, LLCANDACurrent