Application 075673

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLECREAM;TOPICALEQ 0.05% BASE;1%NoNo

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

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
A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075673-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALABRS2001-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075673-001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%CREAM / TOPICALAB2001-05-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075673-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075673-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075673-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075673-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075673-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075673-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075673-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075673-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075673-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075673-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075673-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075673-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075673-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075673-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075673-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075673-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075673-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075673-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075673-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075673-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075673-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075673-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075673-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075673-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075673-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075673-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075673-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075673-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075673-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075673-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075673-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075673-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075673-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075673-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075673-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075673-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075673-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075673-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075673-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075673-001AB1cb3db0bc1861…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEREMEDYREPACK INC.5c064fc8-0426-4608-90ee-93609a7e55472026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
ndc (product): 70518-2352
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATERedpharm Drug56cb4b1c-e0c6-25b2-e063-6394a90ac8332026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.1c18e5fc-bf82-47bc-bfd9-8d3e503569ba2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
ndc (product): 51672-4048
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESportpharm LLC313dde2e-fb82-4786-988b-565d3e003c372026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals Inc.196e24fc-3315-4366-ad40-51b7ea54b2112026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions2eff5585-f013-42f0-b678-bb5406e8188c2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEAdvanced Rx Pharmacy of Tennessee, LLCfe2ec7d2-23c2-e99f-e053-6294a90aa65a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions4320f2b8-ac47-40f4-9275-e7c5506e30e42024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
ndc (product): 50090-3121
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATENORTHSTAR RX LLC8d03b9ba-f7a8-4fbf-9be1-83d815c2be452024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673
ndc (product): 16714-496
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutionsb3f69dc2-2b88-4866-baea-aa3b3ed84fb12023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075673
application number: ANDA075673

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-496Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateNORTHSTAR RX LLCANDACurrent
16714-496Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateNORTHSTAR RX LLCANDACurrent
21695-333Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateRebel Distributors CorpANDACurrent
50090-3121Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateA-S Medication SolutionsANDACurrent
51672-4048Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4048Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4048Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
53002-9742Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateRPK Pharmaceuticals, Inc.ANDACurrent
68071-2324Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2433Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2512Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2352Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-2352Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent
70518-2352Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone DipropionateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30986ORIG2001-05-29