U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090132
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE;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
10/25/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/090132Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2024 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
04/16/2024 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CARVEDILOL PHOSPHATE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204717 IMPAX LABS INC
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090132 SUN PHARM INDUSTRIES
COREG CR CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022012 WAYLIS THERAP

CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204717 IMPAX LABS INC
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090132 SUN PHARM INDUSTRIES
COREG CR CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022012 WAYLIS THERAP

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204717 IMPAX LABS INC
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090132 SUN PHARM INDUSTRIES
COREG CR CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022012 WAYLIS THERAP

CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204717 IMPAX LABS INC
CARVEDILOL PHOSPHATE CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090132 SUN PHARM INDUSTRIES
COREG CR CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022012 WAYLIS THERAP
Back to Top