Home NDC 10337-434 Cutivate
Product NDC 10337-434
11-digit product format 103370434
Labeler code 10337
Product ID 10337-434_37731ce1-15fb-4143-b251-1dacfe5c3b58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluticasone propionate
Dosage form LOTION
Route TOPICAL
Labeler PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application NDA021152
Marketing category NDA
Marketing start 2009-10-05
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N021152-001 CUTIVATE FLUTICASONE PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31
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UTC 2026-02 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL AB RLD, RS 2005-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 N021152-001 7300669 2019-10-20 U-835 Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021152-001 7300669 2019-10-20 U-835 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021152-001 7300669 2019-10-20 U-835 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021152-001 7300669 2019-10-20 U-835 Drug product ea99ee380514…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluticasone propionate ACTIVE INGREDIENT O2GMZ0LF5W CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 fluticasone ACTIVE MOIETY CUT2W21N7U CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Imidurea INACTIVE INGREDIENT M629807ATL CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 Water INACTIVE INGREDIENT 059QF0KO0R CUTIVATE (FLUTICASONE PROPIONATE) LOTION [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10337-434-04 10337043404 1 BOTTLE in 1 CARTON (10337-434-04) > 120 mL in 1 BOTTLE 1 bottle 2009-10-05 0000-00-00 No No Current 10337-434-07 10337043407 7 mL in 1 BOTTLE (10337-434-07) 7 ml 2009-10-05 0000-00-00 No No Current 10337-434-66 10337043466 6 BOTTLE in 1 CARTON (10337-434-66) > 7 mL in 1 BOTTLE 6 bottle 2009-10-05 0000-00-00 No No Current