Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021438
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | BX | Yes | No |
INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | BX | 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 |
---|---|---|---|---|---|---|---|
03/12/2003 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21438ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2023 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021438s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021438Orig1s032ltr.pdf | |
08/16/2021 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021438s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021438Orig1s025ltr.pdf | |
10/24/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/2013 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021438Orig1s016ltr.pdf | |
12/14/2010 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf | |
12/14/2010 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf | |
12/30/2009 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021438s012ltr.pdf | |
01/02/2008 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021438s01ltr_rc.pdf | |
10/22/2004 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21438s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/22/2023 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021438s032lbl.pdf | |
08/16/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021438s025lbl.pdf | |
11/19/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf | |
12/14/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf | |
12/14/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf | |
12/30/2009 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf | |
01/02/2008 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf | |
03/12/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf |
INNOPRAN XL
There are no Therapeutic Equivalents.