Application 078540

Type
ANDA
Sponsor
PAR PHARM

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
A078540-001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18
A078540-002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18
A078540-003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078540-001AB
A078540-002AB
A078540-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-002PROPAFENONE HYDROCHLORIDE325MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-003PROPAFENONE HYDROCHLORIDE425MGCAPSULE, EXTENDED RELEASE / ORALABRS2010-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078540-001PROPAFENONE HYDROCHLORIDE225MGCAPSULE, EXTENDED RELEASE / ORALAB2010-10-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078540-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078540-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078540-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078540-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078540-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078540-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078540-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078540-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078540-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078540-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078540-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078540-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078540-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078540-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078540-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078540-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078540-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078540-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078540-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078540-001AB18072bd15b7f6…

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
Propafenone HydrochloridePROPAFENONE HYDROCHLORIDEStrides Pharma Science Limited3fc0800c-c063-48f8-ab4e-9aa9a4c3841f2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078540
application number: ANDA078540
ndc (product): 64380-185
ndc (product): 64380-184
ndc (product): 64380-186

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-814Propafenonepropafenone hydrochlorideRebel Distributors CorpANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-976Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-976Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical SupplyANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-674Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-685Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2270Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2270Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2271Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2271Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2272Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2272Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2273Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2273Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22623ORIG2013-10-23
9163ORIG2010-10-20