Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210201
Company: ACQ PHARMA

Products on ANDA 210201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	AB	No	No
MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2024	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 210201

MISOPROSTOL

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTOTEC	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	Yes	AB	019268	PFIZER
MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	No	AB	210201	ACQ PHARMA
MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	No	AB	076095	ANI PHARMS
MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	No	AB	216872	MICRO LABS

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTOTEC	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	Yes	AB	019268	PFIZER
MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	No	AB	210201	ACQ PHARMA
MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	No	AB	076095	ANI PHARMS
MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	No	AB	216872	MICRO LABS