Application 203263

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)NoYes
002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)NoYes

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
A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04
A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203263-001AB
A203263-002AB

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 UTC2026-02A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203263-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A203263-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRS2013-02-04782e0a99824c…

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 UTC2026-02A203263-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203263-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203263-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203263-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203263-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203263-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203263-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203263-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203263-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203263-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203263-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203263-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203263-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203263-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203263-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203263-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203263-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203263-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203263-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203263-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203263-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203263-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203263-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203263-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203263-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203263-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203263-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203263-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203263-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203263-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203263-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203263-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203263-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203263-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203263-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203263-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203263-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203263-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203263-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203263-002AB1782e0a99824c…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesf6508535-e7a7-4e50-8d0c-43deda8d0d082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203263
application number: ANDA203263
ndc (product): 68001-493
ndc (product): 68001-492
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDENorthStar RxLLCddf55319-bf62-4ec7-8be2-ef97188837c42026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203263
application number: ANDA203263
ndc (product): 72603-103
ndc (product): 72603-200
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.fbc48fa5-0bfb-4957-b13c-a56bb7a13b562026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203263
application number: ANDA203263
ndc (product): 47335-050
ndc (product): 47335-049

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-049Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-050Doxorubicin HydrochlorideDoxorubicin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
68001-492Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-492Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-493Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-493Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-103Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
72603-200Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53718ORIG2018-04-18
32403ORIG2013-02-05
40283ORIG2013-02-04