Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078065
Company: NORTEC DEV ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG 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
01/26/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078065s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078065lbl.pdf

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; 160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

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