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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216363
Company: GLENMARK PHARMS LTD

Products on ANDA 216363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216363

PROGESTERONE

INSERT;VAGINAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENDOMETRIN	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	Yes	AB	022057	FERRING
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	No	AB	216363	GLENMARK PHARMS LTD
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	No	AB	218391	XIROMED

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