FDA.reportPublic FDA data

Application 019716

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPROLENEBETAMETHASONE DIPROPIONATELOTION, AUGMENTED;TOPICALEQ 0.05% BASEYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019716-001DIPROLENEBETAMETHASONE DIPROPIONATEEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION, AUGMENTED / TOPICALRLD1988-08-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019716-001DIPROLENEEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION, AUGMENTED / TOPICALRLD1988-08-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019716-001DIPROLENEEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION, AUGMENTED / TOPICALRLD1988-08-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019716-001DIPROLENEEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION, AUGMENTED / TOPICALRLD1988-08-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019716-001DIPROLENEEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION, AUGMENTED / TOPICALRLD1988-08-01a50c72e98297…

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEREMEDYREPACK INC.7cacf0ec-3db9-48be-9a76-93ed4a1f042c2026-08-31Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC97dde5f5-a865-4af2-b562-8da72c8475f32026-08-21Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0173ed23-9f7c-466e-9eba-f6859d05f9872026-07-29Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionateBETAMETHASONE DIPROPIONATERedpharm Drug5718b3bd-77b3-8034-e063-6294a90af5e02026-07-21Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutionsb5291e39-40a0-4362-9281-97f5fb4025d92026-05-11Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEAurobindo Pharma Limiteda4f8db3a-0aed-451c-98ba-c4ce376567922026-05-04Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
SernivoBETAMETHASONE DIPROPIONATEPrimus Pharmaceuticals, Inc.b1b3d1b0-da9b-11eb-ad76-0800200c9a662026-04-22Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals, Inc.5683885d-461c-4e7e-bbe8-dc231d7061922026-03-19Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals, Inc.54eff1fc-c611-4929-bb44-c1834c08f5062026-03-19Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutionsabd5a08c-4bb7-46c9-9e2e-0a89c43d46c82026-02-06Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC4f411e41-00dc-47cf-8517-3ff5876e1bf52026-01-30Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC853399f8-95a7-41f3-80e7-7ed8e3ff1a5e2026-01-30Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPrasco Laboratoriesf5b50c00-cc6f-4296-a9ae-b16888cef4dd2025-11-19Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
DIPROLENEBETAMETHASONE DIPROPIONATEOrganon LLC0b9543ad-2ca7-430d-aef9-81c376dc2e6c2025-11-19Warnings, Adverse reactionsName fallback
brand name: DIPROLENE
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionateBETAMETHASONE DIPROPIONATELupin Pharmaceuticals, Inc.216d5b7f-4236-4882-b899-be17cb1a15842025-11-13Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEEncube Ethicals, Inc.7e946599-2fb4-4426-bb59-fbb71d89dac82025-11-11Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBryant Ranch Prepack1d40b962-5d97-4416-b46d-b0785acd261d2025-10-21Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.000ae256-a337-4903-845b-003777a4efa82025-09-26Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBryant Ranch Prepack13196f0a-6daf-4f62-853c-ac2ac261ce432025-09-12Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepackf2c557ea-275b-4ab4-90f4-4003e022214d2025-08-07Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE DIPROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent
0085-0962DIPROLENEbetamethasone dipropionateMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58525SUPPL2019-05-02
58523SUPPL2019-05-02
53587SUPPL2018-04-01
53570SUPPL2018-04-01
11645SUPPL2014-08-15
19113SUPPL2014-08-14
19112SUPPL2006-09-18
11644SUPPL2006-08-28
1525SUPPL2006-04-25
33879SUPPL2005-10-14
1524SUPPL2005-10-14