Home Applications 050615 Application 050615
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLEOCIN T CLINDAMYCIN PHOSPHATE GEL;TOPICAL EQ 1% BASE Yes Yes
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 N050615-001 CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050615-001 AB1
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 · 42 observed 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 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-3331 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3331 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3331 Cleocin T clindamycin phosphate Pharmacia & Upjohn Company LLC NDA Current 0009-3331 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3331 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 59762-3743 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3743 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3743 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3743 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3743 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current