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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076095
Company: ANI PHARMS

Other Important Information from FDA

Products on ANDA 076095

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 076095

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2002	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76095ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076095.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2022	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/27/2010	SUPPL-12	Labeling-Medication Guide		Label is not available on this site.
12/27/2007	SUPPL-4	Labeling		Label is not available on this site.
11/20/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
11/20/2002	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Therapeutic Equivalents for ANDA 076095

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	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	076095	ANI PHARMS
MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	No	AB	216872	MICRO LABS

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