Swiss American Cdmo L L C

FDA Filings

This page includes the latest FDA filings for Swiss American Cdmo L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1649690
• FEI Number: 3001451826
• Name: Swiss-American CDMO,LLC
• Owner & Operator: Swiss-American CDMO, LLC
• Contact Address: 2055 LUNA RD., STE. 126 --; Carrollton TX 75006 US
• Official Correspondent:
  • LESLI M EARLSTON
  • x-866-4162366-2241
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2055 Luna Rd Ste 126 ; CARROLLTON, TX 75006 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
Secura Dimethicone Protectant Smith & Nephew Medical Ltd, Swiss-American CDMO, LLC	Otc Medication	2024-12-18
EltaMD UV Physical Rosy Tint SPF40 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-10-12
Soothe And Cool Treat Medline Industries, LP	Otc Medication	2024-10-10
Mimosa Lane SPF45 R&G Divergency LLC, Swiss-American CDMO, LLC	Otc Medication	2024-08-31
Secura Dimethicone Protectant Smith & Nephew Medical Ltd, Swiss-American CDMO, LLC	Otc Medication	2024-08-22
Secura Moisturizing Cleanser Smith & Nephew Medical Ltd, Swiss American CDMO LLC	Otc Medication	2024-08-17
EltaMD UV Physical SPF41 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-08-06
EltaMD UV SPF35 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-08-02
Dermal Wound Cleanser Smith & Nephew Medical Ltd., Swiss-American CDMO, LLC	Otc Medication	2024-07-16
EltaMD UV Daily Tinted CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-06-16
EltaMD UV Daily CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-06-16
EltaMD UV SPF35 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2024-06-16
EltaMD UV Restore Tinted CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2024-06-12
EltaMD UV Sport SPF50 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2024-06-01
UV Daily Deep Tint CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2024-05-11
EltaMD UV Pure SPF47 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2024-05-11
Chemical Sunscreen SPF50 Swiss-American CDMO, LLC	Otc Medication	2024-05-09
Promescent Absorption, Swiss-American CDMO, LLC	Otc Medication	2024-02-21
EltaMD UV Lip Balm SPF31 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2024-02-21
EltaMD UV Sheer CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-12-06
EltaMD UV Facial SPF30 Plus EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-12-01
EltaMD UV Luminous CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-15
Private Label SPF 50 80 min Water Resistant Swiss-American CDMO, LLC	Otc Medication	2023-11-15
EltaMD Skincare UV AOX Elements SPF50 Tinted CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-15
EltaMD Laser Balm CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-15
Private Label Moisturizing Oil Free Paraben Free SPF43 Swiss-American CDMO, LLC	Otc Medication	2023-11-15
EltaMD UV Daily SPF40 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Daily Tinted SPF40 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Pure SPF47 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Luminous CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
Intense Therapy Lip Balm Mango and Mandarin Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Facial SPF30 Plus EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Shield SPF45 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Restore Tinted CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Clear SPF46 EltaMD, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Restore CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Active CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Physical SPF41 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Sheer CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
Private Label Sunscreen SPF35 40min WR RE126-202 Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Elements SPF44 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Clear Tinted SPF46 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV AOX Mist CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
EltaMD UV Lip Balm SPF31 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-10
Physical Sunscreen SPF50 80 min WR 159-100 Swiss-American CDMO, LLC	Otc Medication	2023-11-10
Intense Therapy Lip Balm Pineapple Mint Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-10
Apostrophe Screen SPF43 Yoderm, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Hims Delay Wipes Hims Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Intense Therapy Lip Balm Asian Pear Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Intense Therapy Lip Balm Black Cherry Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Skinnies SPF30 Sungel Skinnies USA, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Private Label Super Light Oil-Free SPF45 Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Intense Therapy Lip Balm Cucumber Lime Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Promescent Absorption, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Jack Black Intensive Therapy Lip Balm Mango Chili Lime Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Antiseptic Wash Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Skin Protectant Cream 43% Petrolatum Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Intense Therapy Lip Balm Basil Lemon Jack Black, LLC, Swiss-American CDMO, LLC	Otc Medication	2023-11-09
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50 Swiss-American CDMO, LLC	Otc Medication	2023-11-08
Image Skincare Prevention Plus Daily Ultimate Protection Swiss-American CDMO, LLC	Otc Medication	2023-11-08
Image Skincare Prevention Plus Daily Defense Lip Enhancer Swiss-American CDMO, LLC	Otc Medication	2023-11-08
Image Prevention Refiner Primer SPF50 Swiss-American CDMO, LLC	Otc Medication	2023-11-08
Neova DNA Damage Control - Active PHARMA COSMETICS, INC, Swiss-American CDMO, LLC	Otc Medication	2023-10-11
Neova DNA Damage Control - Everyday PHARMA COSMETICS, INC, Swiss-American CDMO, LLC	Otc Medication	2023-10-11
EltaMD UV Sport SPF50 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-10-10
EltaMD UV Sport SPF50 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-09-12
EltaMD UV Facial SPF30 Plus EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-09-12
Soothe And Cool Treat Medline Industries, LP	Otc Medication	2023-08-18
EltaMD UV Physical SPF41 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-08-15
EltaMD UV Restore Tinted CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-08-08
EltaMD UV Sport SPF50 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-07-11
EltaMD UV AOX Mist CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-04-01
Obagi Skintrinsiq Firming Protocol Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC	Otc Medication	2023-03-31
Obagi Skintrinsiq Antioxidant Protocol Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC	Otc Medication	2023-03-31
Obagi Skintrinsiq Clarifiying Protocol Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC	Otc Medication	2023-03-31
Obagi Skintrinsiq Antioxidant Protocol Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC	Otc Medication	2023-03-29
EltaMD UV Daily SPF40 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-03-24
EltaMD UV Clear SPF46 EltaMD, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-03-24
Obagi Skintrinsiq Brightening Protocol Obagi Cosmeceuticals LLC, G.S.COSMECEUTICAL USA, INC., Denison Pharmaceuticals, LLC, Swiss-American CDMO, LLC, TENCO ASSEMBLIES, INC	Otc Medication	2023-03-24
OBAGI-C RX System NORMAL-DRY Obagi Cosmeceuticals LLC, G. S. Cosmeceutical USA, Inc., Universal Packaging Systems, Inc. (DBA Paklab), Swiss American CDMO, LLC, Bay Cities Container Corporation, PURETEK CORPORATION	Prescription Medication	2023-02-08
EltaMD UV Elements SPF44 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-02-07
OBAGI-C RX system NORMAL-oily Obagi Cosmeceuticals LLC, G. S. Cosmeceutical USA, Inc., Swiss American CDMO, LLC, Universal Packaging Systems, Inc. (DBA Paklab), Bay Cities Container Corporation, PURETEK CORPORATION	Prescription Medication	2023-02-03
EltaMD UV Daily SPF40 CP Skin Health Group, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-02-02
EltaMD UV Daily Tinted SPF40 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-02-02
EltaMD UV Clear SPF46 EltaMD, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-02-02
EltaMD UV Restore CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-02-02
EltaMD UV Elements SPF44 CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2023-02-02
EltaMD UV Clear Tinted SPF46 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2023-02-02
NU-DERM system NORMAL-oily OBAGI COSMECEUTICAL LLC, PURETEK CORPORATION, G.S. COSMECEUTICAL USA, INC., Swiss-American CDMO, LLC	Prescription Medication	2023-01-29
Obagi Nu-Derm FX System Normal - Dry Obagi Cosmeceuticals LLC, Swiss-American CDMO, LLC, G. S. Cosmeceutical USA, Inc.	Otc Medication	2023-01-27
Obagi Nu-Derm FX System Normal - Oily Obagi Cosmeceuticals LLC, Swiss-American CDMO, LLC, G. S. Cosmeceutical USA, Inc.	Otc Medication	2023-01-27
nu-derm system normal-dry OBAGI COSMECEUTICAL LLC, Bay Cities Container Corporation, PURETEK CORPORATION, Swiss-American CDMO, LLC, G. S. Cosmeceutical USA, Inc.	Prescription Medication	2023-01-21
NU-DERM System NORMAL-Oily OBAGI COSMECEUTICAL LLC, Bay Cities Container Corporation, PURETEK CORPORATION, G.S. COSMECEUTICAL USA, INC., Swiss-American CDMO, LLC	Prescription Medication	2023-01-21
Acne Blu Salicylic Acid Pads INK Pharmaceuticals, Inc., Swiss-American CDMO, LLC, TRI-PAC, INC.	Otc Medication	2022-12-29
Quinixil V2 Pharma, LLC, Swiss-American CDMO, LLC, Smith & Nephew Medical Ltd, G&W Laboratories, Inc.	Prescription Medication	2022-12-17
EltaMD UV Luminous CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2022-12-17
EltaMD UV Aero EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2022-12-17
EltaMD Laser Balm CP Skin Health Group, Inc, Swiss-American CDMO, LLC	Otc Medication	2022-12-17
EltaMD UV Lip Balm SPF31 EltaMD, Inc., Swiss-American CDMO, LLC	Otc Medication	2022-12-17
Neova DNA Damage Control - Active PHARMA COSMETICS, INC, Swiss-American CDMO, LLC	Otc Medication	2022-11-26
NDC 60232-3537 Swiss-American CDMO, LLC	Image MD Restoring Lip Enhancer SPF15	2022-03-17
NDC 60232-1830 Swiss-American CDMO, LLC	Image Prevention Refiner Primer SPF50	2020-03-06
NDC 60232-1026 Swiss-American CDMO, LLC	Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50	2020-01-31
NDC 60232-1022 Swiss-American CDMO, LLC	Image Skincare Prevention Plus Daily Ultimate Protection	2020-01-31
NDC 60232-0027 Swiss-American CDMO, LLC	Image Skincare Prevention Plus Daily Defense Lip Enhancer	2020-01-02
NDC 60232-0022 Swiss-American CDMO, LLC	Antiseptic Wash	2013-09-05
NDC 60232-0021 Swiss-American CDMO, LLC	Skin Protectant Cream 43% Petrolatum	2013-09-02
NDC 60232-0006 Swiss-American CDMO, LLC	Private Label SPF45 Water Resistant Paraben Free Sunscreen	2011-08-31
NDC 60232-0008 Swiss-American CDMO, LLC	Private Label Super Light Oil-Free SPF45	2011-03-22
NDC 60232-0009 Swiss-American CDMO, LLC	Private Label Antifungal Barrier Cream	2010-11-22
NDC 60232-0007 Swiss-American CDMO, LLC	Private Label Moisturizing Oil Free Paraben Free SPF43	2010-05-07
PMN K962218 | MGQ Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	Carrasyn Hydrogel Wound Dressing	2009-03-09
PMN K961758 | MGQ Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	Carrasyn Spray Hydrogel	2009-02-03
PMN K022670 | FRO Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	Carraklenz	2009-01-19
PMN K073610 | FRO Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	EltaMD Dermal Wound Cleanser	2008-10-29
PMN K052643 | FRO Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	EpiCeram Skin Barrier Emulsion	2008-10-29
PMN K071703 | FRO Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	Solox Gel	2007-10-11
PMN K071703 | FRO Swiss-American CDMO,LLC [Swiss-American CDMO, LLC]	Elta Silver Antimicrobial Wound Gel	2007-10-11

Similar & Related FDA Registered Companies

• Smith & Nephew Medical Ltd
• CP Skin Health Group, Inc
• Medline Industries, LP
• R&G Divergency LLC
• EltaMD, Inc.
• Absorption
• Jack Black, LLC
• Yoderm, Inc.
• Hims Inc.
• Skinnies USA, Inc.
• PHARMA COSMETICS, INC
• Obagi Cosmeceuticals LLC
• G.S.COSMECEUTICAL USA, INC.
• Denison Pharmaceuticals, LLC
• TENCO ASSEMBLIES, INC
• Universal Packaging Systems, Inc. (DBA Paklab)
• Bay Cities Container Corporation
• PURETEK CORPORATION
• OBAGI COSMECEUTICAL LLC
• INK Pharmaceuticals, Inc.
• TRI-PAC, INC.
• V2 Pharma, LLC
• G&W Laboratories, Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061348476	Hong Kong,Hong Kong -> Long Beach, California	VINYL GLOVES (NON-MEDICAL DEVICE) .	800 CTN