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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079116
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription AB No No
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription AB No No
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription AB No No
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/20/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/09/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/09/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/24/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/24/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/24/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/24/2015 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

01/24/2015 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

05/07/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

RAMIPRIL

CAPSULE;ORAL; 1.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALTACE RAMIPRIL 1.25MG CAPSULE;ORAL Prescription Yes AB 019901 KING PHARMS LLC
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 202392 ACCORD HLTHCARE
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 079116 APOTEX
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 078745 CHARTWELL MOLECULAR
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 077900 HIKMA
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 1.25MG CAPSULE;ORAL Prescription No AB 078832 ZYDUS PHARMS USA

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALTACE RAMIPRIL 2.5MG CAPSULE;ORAL Prescription Yes AB 019901 KING PHARMS LLC
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 202392 ACCORD HLTHCARE
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 079116 APOTEX
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 078745 CHARTWELL MOLECULAR
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 077900 HIKMA
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 2.5MG CAPSULE;ORAL Prescription No AB 078832 ZYDUS PHARMS USA

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALTACE RAMIPRIL 5MG CAPSULE;ORAL Prescription Yes AB 019901 KING PHARMS LLC
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 202392 ACCORD HLTHCARE
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 079116 APOTEX
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 078745 CHARTWELL MOLECULAR
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 077900 HIKMA
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 5MG CAPSULE;ORAL Prescription No AB 078832 ZYDUS PHARMS USA

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALTACE RAMIPRIL 10MG CAPSULE;ORAL Prescription Yes AB 019901 KING PHARMS LLC
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 202392 ACCORD HLTHCARE
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 079116 APOTEX
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 091604 AUROBINDO PHARMA LTD
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078745 CHARTWELL MOLECULAR
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078191 DR REDDYS LABS LTD
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 077900 HIKMA
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 077626 LUPIN
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 076549 WATSON LABS
RAMIPRIL RAMIPRIL 10MG CAPSULE;ORAL Prescription No AB 078832 ZYDUS PHARMS USA
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