Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204717
Company: IMPAX LABS INC
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
05/07/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204717Orig1s000TAltr.pdf

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 SMITHKLINE BEECHAM

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 SMITHKLINE BEECHAM

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 SMITHKLINE BEECHAM

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 SMITHKLINE BEECHAM

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