Home NDC 40076-061 EVOCLIN
Product NDC 40076-061
11-digit product format 400760061
Labeler code 40076
Product ID 40076-061_26340790-e267-444d-8463-80c0b3894617
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Prestium Pharma, Inc.
Application NDA050801
Marketing category NDA
Marketing start 2014-08-19
Marketing end 2020-06-30
Substance CLINDAMYCIN PHOSPHATE
Active strength 10 mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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date N050801-001 EVOCLIN CLINDAMYCIN PHOSPHATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22
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 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050801-001 EVOCLIN 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM / TOPICAL RLD 2004-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL RLD 2004-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050801-001 EVOCLIN 1% AEROSOL, FOAM / TOPICAL AT RLD, RS 2004-10-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050801-001 7374747 2024-01-23 U-921 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050801-001 7141237 2024-02-03 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050801-001 7374747 2024-01-23 U-921 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050801-001 7141237 2024-02-03 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050801-001 7374747 2024-01-23 U-921 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050801-001 7141237 2024-02-03 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050801-001 7374747 2024-01-23 U-921 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050801-001 7141237 2024-02-03 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050801-001 7374747 2024-01-23 U-921 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050801-001 7141237 2024-02-03 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050801-001 7374747 2024-01-23 U-921 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050801-001 7141237 2024-02-03 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050801-001 7374747 2024-01-23 U-921 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050801-001 7141237 2024-02-03 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050801-001 7374747 2024-01-23 U-921 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050801-001 7141237 2024-02-03 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050801-001 7374747 2024-01-23 U-921 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050801-001 7141237 2024-02-03 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050801-001 7374747 2024-01-23 U-921 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050801-001 7141237 2024-02-03 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050801-001 7374747 2024-01-23 U-921 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050801-001 7141237 2024-02-03 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050801-001 7374747 2024-01-23 U-921 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050801-001 7141237 2024-02-03 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050801-001 7374747 2024-01-23 U-921 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050801-001 7141237 2024-02-03 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050801-001 7374747 2024-01-23 U-921 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050801-001 7141237 2024-02-03 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050801-001 7374747 2024-01-23 U-921 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050801-001 7141237 2024-02-03 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050801-001 7374747 2024-01-23 U-921 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050801-001 7141237 2024-02-03 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050801-001 7374747 2024-01-23 U-921 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050801-001 7141237 2024-02-03 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050801-001 7374747 2024-01-23 U-921 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050801-001 7141237 2024-02-03 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050801-001 7374747 2024-01-23 U-921 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050801-001 7141237 2024-02-03 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050801-001 7374747 2024-01-23 U-921 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050801-001 7141237 2024-02-03 Drug product 3f01610625f2…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN PHOSPHATE ACTIVE INGREDIENT EH6D7113I8 EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R EVOCLIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [PRESTIUM PHARMA, INC.] 2