CARVEDILOL PHOSPHATE از شرکت IMPAX LABS INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CARVEDILOL PHOSPHATE از شرکت IMPAX LABS INC

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 WOODWARD

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 WOODWARD

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 WOODWARD

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 WOODWARD
حتما بخوانید : BILIVIST از شرکت BAYER HLTHCARE
بخوانید  CHLORPHENIRAMINE MALEATE از شرکت AVANTHI INC
به بالای صفحه بردن