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2001P-0156: ANDA Suitability for Ketamine Hydrochloride Injection

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
CP1 03/28/2001 03/29/2001 International Bioniche Pharma (Canada) Ltd. Letter
Bioniche Labeling
Reference-Labeling
ACK 3/29/01
Signature: Rhonda Noll
ACK1 03/29/2001 03/29/2001 Other Organization HFA-305 pdf
Signature: Lyle D. Jaffe
PAV1 08/21/2001 08/21/2001 Other Organization HFD-600 to Bioniche Pharma (Canada) LTD pdf SEE CP1 CLOSED
Signature: Gary J Buehler
SUP1 08/24/2001 08/24/2001 International Bioniche Pharma (Canada) Ltd. pdf
Signature: Rhonda Noll

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Page last updated: August 22, 2007