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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076204
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription AB No No
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/08/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076204.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/02/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/15/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/31/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078454 APOTEX INC
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 077536 CHARTWELL RX
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 090416 GLENMARK GENERICS
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 076204 TEVA

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 078454 APOTEX INC
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 077536 CHARTWELL RX
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090416 GLENMARK GENERICS
MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076204 TEVA
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