Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075041
Company: ALKERMES GAINESVILLE

Products on ANDA 075041

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075041

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
09/10/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075041

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf