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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021438
Company: ANI PHARMS

Products on NDA 021438

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021438

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

Labels for NDA 021438

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

Therapeutic Equivalents for NDA 021438

INNOPRAN XL

There are no Therapeutic Equivalents.

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