Home Applications 214668 Application 214668
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE GEL;TOPICAL EQ 1% BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214668-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214668-001 AB2
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214668-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB2 2022-08-05 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69238-2031 Clindamycin Phosphate Clindamycin Phosphate Amneal Pharmaceuticals NY LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72033 ORIG 2022-09-07