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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216338
Company: TEVA PHARMS INC

Products on NDA 216338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216338Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216338Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216338Orig1s001ltr.pdf

Labels for NDA 216338

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s001lbl.pdf
05/11/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216338s000lbl.pdf

Therapeutic Equivalents for NDA 216338

PACLITAXEL

POWDER;INTRAVENOUS; 100MG/VIAL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABRAXANE	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	021660	BRISTOL-MYERS
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	211875	AM REGENT
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	209657	CIPLA
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	212700	HENGRUI PHARMA
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	217877	MYLAN
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AB	216355	SHUANGCHENG
PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AB	216338	TEVA PHARMS INC

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