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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075395
Company: ZYDUS HLTHCARE

Products on ANDA 075395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75395ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2015	SUPPL-25	Labeling		Label is not available on this site.
10/31/2007	SUPPL-18	Labeling		Label is not available on this site.
06/14/2007	SUPPL-13	Labeling		Label is not available on this site.
06/14/2007	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/09/2002	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/09/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
08/23/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075395

ISOSORBIDE MONONITRATE

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216557	AUROBINDO PHARMA
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075155	CHARTWELL MOLECULAR
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075522	DEXCEL LTD
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210918	RICONPHARMA LLC
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214115	SHANDONG
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200270	TORRENT PHARMS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075395	ZYDUS HLTHCARE

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216557	AUROBINDO PHARMA
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075155	CHARTWELL MOLECULAR
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075522	DEXCEL LTD
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210918	RICONPHARMA LLC
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214115	SHANDONG
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200495	TORRENT PHARMS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075395	ZYDUS HLTHCARE

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216557	AUROBINDO PHARMA
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075155	CHARTWELL MOLECULAR
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210822	DEXCEL LTD
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210918	RICONPHARMA LLC
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214115	SHANDONG
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200495	TORRENT PHARMS
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075395	ZYDUS HLTHCARE

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