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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207563
Company: NOVAST LABS

Products on ANDA 207563

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207563Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/23/2020	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/06/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/06/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207563

DOCETAXEL

INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215744	ALEMBIC
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214575	EUGIA PHARMA
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213510	GLAND PHARMA LTD
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022234	HOSPIRA INC
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209634	MEITHEAL
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210848	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207563	NOVAST LABS
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201525	SANDOZ

INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215744	ALEMBIC
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214575	EUGIA PHARMA
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213510	GLAND PHARMA LTD
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022234	HOSPIRA INC
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209634	MEITHEAL
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208859	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207563	NOVAST LABS
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201525	SANDOZ

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