Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016762
Company: AKRIMAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDERAL PROPRANOLOL HYDROCHLORIDE 10MG TABLET; ORAL Prescription None No No
INDERAL PROPRANOLOL HYDROCHLORIDE 20MG TABLET; ORAL Prescription None No No
INDERAL PROPRANOLOL HYDROCHLORIDE 40MG TABLET; ORAL Prescription None No No
INDERAL PROPRANOLOL HYDROCHLORIDE 60MG TABLET; ORAL Prescription None No No
INDERAL PROPRANOLOL HYDROCHLORIDE 80MG TABLET; ORAL Prescription None 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
09/04/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016418s080,016762s017,017683s008ltr.pdf
02/14/1990 SUPPL-16 Labeling

Label is not available on this site.

07/25/1978 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1978 SUPPL-12 Labeling

Label is not available on this site.

09/21/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1975 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf

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