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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021359
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RECTIV NITROGLYCERIN 0.4% OINTMENT;INTRA-ANAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/2011 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021359s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359_rectiv_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2024 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021359Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021359Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/23/2024 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021359Orig1s005lbl.pdf
06/21/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf

RECTIV

OINTMENT;INTRA-ANAL; 0.4%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.4% OINTMENT;INTRA-ANAL Prescription No AB 216103 COSETTE
RECTIV NITROGLYCERIN 0.4% OINTMENT;INTRA-ANAL Prescription Yes AB 021359 ABBVIE
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