Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075297
Company: TEVA PHARMS USA

Products on ANDA 075297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-297_Paclitaxel_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75297ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-297_Paclitaxel.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/04/2002	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/14/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
08/14/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
10/23/2002	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Labels for ANDA 075297

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-297_Paclitaxel_prntlbl.pdf