Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091033
Company: HIKMA FARMACEUTICA

Products on ANDA 091033

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 091033

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091033

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