Home Applications 050767 Application 050767
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLEOCIN CLINDAMYCIN PHOSPHATE SUPPOSITORY;VAGINAL 100MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050767-001 CLEOCIN CLINDAMYCIN PHOSPHATE 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050767-001 CLEOCIN 100MG SUPPOSITORY / VAGINAL RLD, RS 1999-08-13 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N050767-001 6495157 2020-07-20 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N050767-001 6495157 2020-07-20 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050767-001 6495157 2020-07-20 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050767-001 6495157 2020-07-20 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050767-001 6495157 2020-07-20 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050767-001 6495157 2020-07-20 Drug product ea99ee380514…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cleocin CLINDAMYCIN PHOSPHATE Pharmacia & Upjohn Company LLC 3db26227-208d-4fdd-8426-1d9be5cda9b4 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 050767 application number: NDA050767 ndc (product): 0009-7667
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-7667 Cleocin clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-7667 Cleocin clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-7667 Cleocin clindamycin phosphate Pharmacia & Upjohn Company LLC NDA Current 0009-7667 Cleocin clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-7667 Cleocin clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-7667 Cleocin clindamycin phosphate Pharmacia & Upjohn Company LLC NDA Current 63539-011 Cleocin clindamycin phosphate U.S. Pharmaceuticals NDA Current