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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075906
Company: FRESENIUS KABI USA

Products on ANDA 075906

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGESTERONE	PROGESTERONE	50MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75906ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/05/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
01/24/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075906

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf

Therapeutic Equivalents for ANDA 075906

PROGESTERONE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROGESTERONE	PROGESTERONE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	210965	EUGIA PHARMA
PROGESTERONE	PROGESTERONE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	075906	FRESENIUS KABI USA
PROGESTERONE	PROGESTERONE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	091033	HIKMA FARMACEUTICA
PROGESTERONE	PROGESTERONE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	215634	XIROMED

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