Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020768
Company: IPR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOMIG ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription AB Yes No
ZOMIG ZOLMITRIPTAN 5MG TABLET;ORAL 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
11/25/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020768_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020768Orig1s023,021231Orig1s014,021450Orig1s010Ltr.pdf
03/12/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/14/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
09/14/2012 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
08/11/2010 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf
01/08/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf
11/16/2004 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf
05/21/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf
10/09/2002 SUPPL-10 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020768_S010_ZOMIG_TABLETS.pdf
12/18/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/12/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/29/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768s6ltr.pdf
02/14/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/29/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/01/2000 SUPPL-3 Labeling

Label is not available on this site.

02/16/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf
09/14/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
09/14/2012 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
08/11/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf
11/16/2004 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf

ZOMIG

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 204041 AJANTA PHARMA LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 204232 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 207021 AUROBINDO PHARMA LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 201779 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 204284 INVAGEN PHARMS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 202279 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 203772 MACLEODS PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 207867 PLD ACQUISITIONS LLC
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 090861 TEVA PHARMS USA
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 206973 TWI PHARMS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 203019 ZYDUS PHARMS
ZOMIG ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription Yes AB 020768 IPR

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 204041 AJANTA PHARMA LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 204232 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 207021 AUROBINDO PHARMA LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 201779 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 204284 INVAGEN PHARMS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 202279 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 203772 MACLEODS PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 207867 PLD ACQUISITIONS LLC
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 090861 TEVA PHARMS USA
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 206973 TWI PHARMS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 203019 ZYDUS PHARMS
ZOMIG ZOLMITRIPTAN 5MG TABLET;ORAL Prescription Yes AB 020768 IPR

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