Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021359
Company: ABBVIE
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 |