Drugs@FDA: FDA-Approved Drugs
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 |