Application 211872

Type
ANDA
Sponsor
SOLARIS PHARMA CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEGEL;TOPICALEQ 1% BASENoNo

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
A211872-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211872-001AB1

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 UTC2026-02A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2020-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2020-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2020-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2020-07-29c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211872-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12020-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211872-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211872-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211872-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211872-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211872-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211872-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211872-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211872-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211872-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211872-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211872-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211872-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211872-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211872-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211872-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211872-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211872-001AB114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211872-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211872-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211872-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211872-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211872-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211872-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211872-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211872-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211872-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211872-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211872-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211872-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211872-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A211872-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A211872-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211872-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211872-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211872-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211872-001AB11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211872-001AB11a50c72e98297…

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
Clindamycin PhosphateCLINDAMYCIN PHOSPHATESolaris Pharma Corporationb46941a9-e75f-48f7-b426-03f3074997132025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211872
application number: ANDA211872
ndc (product): 73473-300

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
73473-300Clindamycin Phosphateclindamycin phosphateSolaris Pharma CorporationANDACurrent
73473-300Clindamycin Phosphateclindamycin phosphateSolaris Pharma CorporationANDACurrent