Application 209227

Type
ANDA
Sponsor
GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo
002ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL500MGNoNo

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
A209227-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16
A209227-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209227-001AB
A209227-002AB

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 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-163f01610625f2…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209227-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209227-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209227-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209227-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209227-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209227-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209227-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209227-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209227-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209227-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209227-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209227-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209227-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209227-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209227-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209227-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209227-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209227-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209227-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209227-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209227-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209227-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209227-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209227-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209227-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209227-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209227-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209227-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209227-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209227-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209227-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209227-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209227-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209227-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209227-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209227-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209227-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209227-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209227-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209227-001AB13f01610625f2…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
abiraterone acetateABIRATERONE ACETATENORTHSTAR RX LLC42d5baa8-aca7-49d8-9c24-9d87b707ec202026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209227
application number: ANDA209227
ndc (product): 72603-111
ndc (product): 72603-110
abiraterone acetateABIRATERONE ACETATEGlenmark Pharmaceuticals Inc., USAba32c453-a231-452a-a6d9-b3e57afb2e752026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209227
application number: ANDA209227
ndc (product): 68462-135
ndc (product): 68462-882

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-135abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-882abiraterone acetateabiraterone acetateGlenmark Pharmaceuticals Inc., USAANDACurrent
72603-110abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent
72603-110abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent
72603-111abiraterone acetateabiraterone acetateNORTHSTAR RX LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57749ORIG2019-02-21