Application 211450

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAEROSOL, FOAM;TOPICAL0.05%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
A211450-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211450-001AB2

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211450-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22019-09-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211450-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211450-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211450-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211450-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211450-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211450-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211450-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211450-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211450-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211450-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211450-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211450-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211450-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211450-001AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211450-001AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211450-001AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211450-001AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211450-001AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211450-001AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211450-001AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211450-001AB2187673890dc5c…
2021-03-12 10:30 UTC2021-03A211450-001AB215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211450-001AB218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211450-001AB21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211450-001AB213f01610625f2…
2019-09-15 20:21 UTC2019-09A211450-001AB21b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211450-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211450-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211450-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211450-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211450-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211450-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211450-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A211450-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A211450-001AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211450-001AB213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211450-001AB21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211450-001AB21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211450-001AB21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211450-001AB21a50c72e98297…

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
clobetasol propionateCLOBETASOL PROPIONATEGlenmark Pharmaceuticals Inc., USA6a3ad15e-2874-40d0-9e69-105b369c8cfc2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211450
application number: ANDA211450
ndc (product): 68462-625

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-625clobetasol propionateclobetasol propionateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-625clobetasol propionateclobetasol propionateGlenmark Pharmaceuticals Inc., USAANDACurrent