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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204412
Company: ABBVIE

Products on NDA 204412

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DELZICOL	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204412

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2013	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204412Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204412_delzicol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204412s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204412Orig1s016ltr.pdf
11/01/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204412s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204412Orig1s015ltr.pdf
10/01/2020	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204412s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204412Orig1s012ltr.pdf
05/21/2020	SUPPL-11		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204412s011lbl.pdf
07/27/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204412s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf
09/09/2015	SUPPL-6	Efficacy-Pediatric	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204412Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204412Orig1s006.pdf
12/02/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/27/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s004ltr.pdf
04/28/2014	SUPPL-3	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s003ltr.pdf
10/22/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/09/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204412

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204412s016lbl.pdf
11/01/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204412s015lbl.pdf
10/01/2020	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204412s012lbl.pdf
10/01/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204412s012lbl.pdf
05/21/2020	SUPPL-11	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204412s011lbl.pdf
07/27/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204412s008lbl.pdf
09/09/2015	SUPPL-6	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf
10/27/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf
04/28/2014	SUPPL-3	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf
02/01/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf

Therapeutic Equivalents for NDA 204412

DELZICOL

CAPSULE, DELAYED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DELZICOL	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204412	ABBVIE
MESALAMINE	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	207873	TEVA PHARMS USA

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