Amphastar Nanjing Pharmaceuticals Inc

FDA Filings

This page includes the latest FDA filings for Amphastar Nanjing Pharmaceuticals Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009805706
• FEI Number: 3009805706
• Name: AMPHASTAR NANJING PHARMACEUTICALS INC.
• Owner & Operator: Amphastar Nanjing Pharmaceuticals Inc.
• Contact Address: No.5 Xinghe Road Nanjing Economic and Technological Devel; Nanjing CN-32 Jiangsu 210038 CN
• Official Correspondent:
  • Kevin He
  • 86-025-85807880-512
• US Agent:
  • Gisela Sharp
  • International Medication Systems, Limited
  • 909 9424176
  • 626 4595592
  • GiselaS@ims-limited.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.5 Xinghe Road Nanjing Economic and Technological Development Z; Nanjing Jiangsu, 210038 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K201545 Amphastar Nanjing Pharmaceuticals, Inc.	Surgical Face Mask	2021-02-12
NDC 52221-125 Amphastar Nanjing Pharmaceuticals, Inc.		2020-08-26
LRJ AMPHASTAR NANJING PHARMACEUTICALS INC.	Wash-free Alcohol Bacteriostatic Gel	2020-03-30
KHA AMPHASTAR NANJING PHARMACEUTICALS INC.	Earloop Face Mask	2020-03-04
KHA AMPHASTAR NANJING PHARMACEUTICALS INC.	EARLOOP NANOMETER FACE MASK	2020-03-04
NDC 52221-124 Amphastar Nanjing Pharmaceuticals, Inc.		2019-07-25
NDC 52221-123 Amphastar Nanjing Pharmaceuticals, Inc.		2018-12-04
NDC 52221-114 Amphastar Nanjing Pharmaceuticals, Inc.		2018-07-25
NDC 52221-122 Amphastar Nanjing Pharmaceuticals, Inc.		2018-05-18
NDC 52221-121 Amphastar Nanjing Pharmaceuticals, Inc.		2017-06-07
NDC 52221-120 Amphastar Nanjing Pharmaceuticals, Inc.		2017-06-07
NDC 52221-119 Amphastar Nanjing Pharmaceuticals, Inc.		2017-06-07
NDC 52221-118 Amphastar Nanjing Pharmaceuticals, Inc.		2016-10-24
NDC 52221-117 Amphastar Nanjing Pharmaceuticals, Inc.		2015-12-22
NDC 52221-113 Amphastar Nanjing Pharmaceuticals, Inc.		2015-12-01
NDC 52221-116 Amphastar Nanjing Pharmaceuticals, Inc.		2015-10-30
NDC 52221-115 Amphastar Nanjing Pharmaceuticals, Inc.		2015-08-25
NDC 52221-112 Amphastar Nanjing Pharmaceuticals, Inc.		2015-08-21
NDC 52221-110 Amphastar Nanjing Pharmaceuticals, Inc.		2015-07-10
NDC 52221-201 Amphastar Nanjing Pharmaceuticals, Inc.		2015-06-17
NDC 52221-111 Amphastar Nanjing Pharmaceuticals, Inc.		2015-05-14
NDC 52221-108 Amphastar Nanjing Pharmaceuticals, Inc.		2014-07-21
NDC 52221-107 Amphastar Nanjing Pharmaceuticals, Inc.		2014-07-21
NDC 52221-103 Amphastar Nanjing Pharmaceuticals,Inc.		2014-06-01
NDC 52221-106 Amphastar Nanjing Pharmaceuticals, Inc.		2013-12-01
NDC 52221-105 Amphastar Nanjing Pharmaceuticals, Inc.		2013-12-01
NDC 52221-104 Amphastar Nanjing Pharmaceuticals, Inc.		2013-12-01
NDC 52221-101 Amphastar Nanjing Pharmaceuticals, Inc.		2010-04-12