Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017443
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DANTRIUM DANTROLENE SODIUM 25MG CAPSULE;ORAL Prescription AB Yes No
DANTRIUM DANTROLENE SODIUM 100MG CAPSULE;ORAL Prescription AB Yes Yes
DANTRIUM DANTROLENE SODIUM 50MG CAPSULE;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/15/1974 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2015 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

03/11/2014 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

07/17/2012 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf
07/17/2012 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf
10/30/1997 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2012 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf
03/14/1997 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1996 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/17/2012 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017443Orig1s043,s046,s048,s049ltr.pdf
01/24/1992 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1991 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1990 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1989 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1985 SUPPL-36 Labeling

Label is not available on this site.

05/20/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1983 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1983 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1983 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1983 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1983 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/29/1982 SUPPL-25 Labeling

Label is not available on this site.

10/09/1981 SUPPL-24 Labeling

Label is not available on this site.

03/18/1981 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/17/1979 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1979 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/05/1979 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/27/1977 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/25/1977 SUPPL-16 Labeling

Label is not available on this site.

06/15/1977 SUPPL-15 Labeling

Label is not available on this site.

06/15/1977 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/12/1976 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/16/1976 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/12/1976 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/10/1975 SUPPL-9 Labeling

Label is not available on this site.

07/15/1975 SUPPL-8 Labeling

Label is not available on this site.

11/20/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1975 SUPPL-6 Labeling

Label is not available on this site.

02/26/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2012 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf
07/17/2012 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf
07/17/2012 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf
07/17/2012 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017443s043s046s048s049lbl.pdf

DANTRIUM

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANTRIUM DANTROLENE SODIUM 25MG CAPSULE;ORAL Prescription Yes AB 017443 PAR STERILE PRODUCTS
DANTROLENE SODIUM DANTROLENE SODIUM 25MG CAPSULE;ORAL Prescription No AB 076686 ELITE LABS INC
DANTROLENE SODIUM DANTROLENE SODIUM 25MG CAPSULE;ORAL Prescription No AB 076856 IMPAX LABS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANTRIUM DANTROLENE SODIUM 100MG CAPSULE;ORAL Prescription Yes AB 017443 PAR STERILE PRODUCTS
DANTROLENE SODIUM DANTROLENE SODIUM 100MG CAPSULE;ORAL Prescription No AB 076686 ELITE LABS INC
DANTROLENE SODIUM DANTROLENE SODIUM 100MG CAPSULE;ORAL Prescription No AB 076856 IMPAX LABS

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANTRIUM DANTROLENE SODIUM 50MG CAPSULE;ORAL Prescription Yes AB 017443 PAR STERILE PRODUCTS
DANTROLENE SODIUM DANTROLENE SODIUM 50MG CAPSULE;ORAL Prescription No AB 076686 ELITE LABS INC
DANTROLENE SODIUM DANTROLENE SODIUM 50MG CAPSULE;ORAL Prescription No AB 076856 IMPAX LABS

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