Home Applications 050537 Application 050537
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 SOLUTION;TOPICAL EQ 1% BASE Yes Yes 002 CLEOCIN CLINDAMYCIN PHOSPHATE SWAB;TOPICAL EQ 1% BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050537-001 CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD, Approved before 1982 N050537-002 CLEOCIN CLINDAMYCIN PHOSPHATE EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SWAB / TOPICAL RLD 1994-02-22
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N050537-001 CLEOCIN T EQ 1% BASE SOLUTION / TOPICAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050537-002 CLEOCIN EQ 1% BASE SWAB / TOPICAL RLD 1994-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050537-001 CLEOCIN T EQ 1% BASE SOLUTION / TOPICAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050537-002 CLEOCIN EQ 1% BASE SWAB / TOPICAL RLD 1994-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050537-001 CLEOCIN T EQ 1% BASE SOLUTION / TOPICAL RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050537-002 CLEOCIN EQ 1% BASE SWAB / TOPICAL RLD 1994-02-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050537-001 CLEOCIN T EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050537-002 CLEOCIN EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SWAB / TOPICAL RLD 1994-02-22 a50c72e98297…
Observed Orange Book normalized TE 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 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-3116 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3116 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3116 Cleocin T clindamycin phosphate Pharmacia & Upjohn Company LLC NDA Current 0009-3116 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 0009-3116 Cleocin T clindamycin phosphate Pharmacia and Upjohn Company LLC NDA Current 59762-3728 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3728 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3728 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3728 clindamycin phosphate clindamycin phosphate Greenstone LLC NDA AUTHORIZED GENERIC Current