Application 212928

Type
ANDA
Sponsor
TWI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL225MGNoNo
002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL325MGNoNo
003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL425MGNoNo

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
A212928-001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18
A212928-002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18
A212928-003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212928-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2020-06-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212928-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212928-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212928-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212928-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212928-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212928-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212928-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212928-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212928-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212928-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212928-003AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212928-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212928-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212928-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212928-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212928-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212928-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212928-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212928-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212928-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A212928-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212928-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212928-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A212928-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212928-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212928-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A212928-003AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212928-001AB16a51e52b5d6a…

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
propafenone hydrochloridePROPAFENONE HYDROCHLORIDENorthstar Rx LLC2ecd6452-ccc3-493f-9a4a-69f0fbf67a422026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: propafenone hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEBryant Ranch Prepackc8ad1f0f-0e95-4868-a2af-e193c18338412026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEBryant Ranch Prepackfaa8e971-4b4f-43db-be97-33acc16dcdc72026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEBryant Ranch Prepack80f174e1-f249-4f34-806d-20e6430844292026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEA-S Medication Solutions41b4e503-60a6-4662-a6f9-46ecf93d930a2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEStrides Pharma Science Limited3fc0800c-c063-48f8-ab4e-9aa9a4c3841f2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEBryant Ranch Prepack680a803d-3d4d-4ca3-b1ce-7d7e3ff8a6262026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEBryant Ranch Prepack5c8cebcd-699f-4c4c-900b-94e0fe5193452026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEBryant Ranch Prepack739b7624-952d-4343-b720-974d30e284d92026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
propafenone hydrochloridePROPAFENONE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAd818af31-2535-4595-82fe-fd7abf66fd6c2026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: propafenone hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEUpsher-Smith Laboratories, LLC8aa6f58a-2980-4caa-9c54-d55d69d5d1322025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEGolden State Medical Supply, Inc.7202aed6-40a9-2bff-e053-2a95a90ae7522025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEBryant Ranch Prepacka6ac2a70-e0ec-4fcd-8732-5f1637be1e602025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEAmerican Health Packagingda08c286-b930-463a-858a-efc54f12019f2025-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEBryant Ranch Prepack617faff7-d9e4-477d-ab2c-aded5c129a862025-10-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEAmerican Health Packaging343e4ad7-05e2-4e6c-8f8e-91c07739cae22025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEANI Pharmaceuticals, Inc.8d1be333-be2b-4064-86a4-c2ad9ad07b832025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science Limitedc65253ab-937f-4982-b841-69c2b9f9ccdb2025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDEStrides Pharma Science Limiteda96f9c6f-4c9c-4406-bca8-08bf9a4af1f42025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROPAFENONE HYDROCHLORIDE
generic name: PROPAFENONE HYDROCHLORIDE
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEAurobindo Pharma Limited1c4fc726-3f5b-4b12-a66e-727c5133d1d92025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Propafenone Hydrochloride
generic name: PROPAFENONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-085Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
24979-086Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
24979-087Propafenone HydrochloridepropafenoneTWi Pharmaceuticals, Inc.ANDACurrent
51407-477Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
51407-478Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
51407-479Propafenone HydrochloridepropafenoneGolden State Medical Supply, Inc.ANDACurrent
71205-940Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-940Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-941Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-941Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-942Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent
71205-942Propafenone HydrochloridepropafenoneProficient Rx LPANDACurrent