Application 208657

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

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

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
A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15
A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208657-001AB
A208657-002AB

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 UTC2026-02A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208657-001DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A208657-002DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2017-05-15782e0a99824c…

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 UTC2026-02A208657-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208657-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208657-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208657-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208657-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208657-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208657-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208657-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208657-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208657-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208657-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208657-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208657-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208657-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208657-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208657-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208657-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208657-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208657-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208657-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208657-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208657-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208657-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208657-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208657-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208657-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208657-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208657-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208657-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208657-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208657-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208657-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208657-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208657-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208657-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208657-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208657-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208657-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208657-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208657-002AB1782e0a99824c…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesf1a12eb5-5bdc-45f4-843e-0c971535b1842022-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208657
application number: ANDA208657
ndc (product): 68001-345

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-742Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
16714-856Doxorubicin HydrochlorideDoxorubicin HydrochlorideNorthStar RxLLCANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-283Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-541Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-682Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
43598-683Doxorubicin HydrochlorideDoxorubicin HydrochlorideDr. Reddy's Laboratories IncANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-345Doxorubicin HydrochlorideDoxorubicin HydrochlorideBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62202ORIG2020-03-19