FDA.reportPublic FDA data

Application 216193

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
003CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216193-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24
A216193-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24
A216193-003CARBAMAZEPINECARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24

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 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-002CARBAMAZEPINE200MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216193-003CARBAMAZEPINE400MGTABLET, EXTENDED RELEASE / ORAL2023-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216193-001CARBAMAZEPINE100MGTABLET, EXTENDED RELEASE / ORAL2023-03-248072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216193-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216193-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216193-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216193-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216193-003AB1053a50430f4f…

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
CarbamazepineCARBAMAZEPINEAjanta Pharma USA Inc.2e3c4854-89a1-4e3f-88d4-e164829585fb2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216193
application number: ANDA216193