Drugs@FDA: FDA-Approved Drugs
Company: SS PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROCALTROL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ROCALTROL | CALCITRIOL | 0.5MCG | 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 |
|---|---|---|---|---|---|---|---|
| 08/17/1978 | 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 |
|---|---|---|---|---|---|
| 02/22/2010 | SUPPL-38 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018044s038ltr.pdf |
| 07/07/2004 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf |
| 11/12/2001 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf |
| 12/15/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-25 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18044s25ltr.pdf |
| 10/22/1996 | SUPPL-24 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf |
| 05/26/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1995 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1991 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1990 | SUPPL-19 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf |
| 04/08/1991 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf |
| 04/27/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/20/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1986 | SUPPL-12 | Efficacy |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1986 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/22/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/10/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1980 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1982 | SUPPL-4 | Efficacy |
Label is not available on this site. |
||
| 11/09/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
ROCALTROL
CAPSULE;ORAL; 0.25MCG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 203289 | AMNEAL PHARMS |
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 091174 | BIONPHARMA |
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 076917 | HIKMA |
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 091356 | STRIDES PHARMA |
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 204556 | SUN PHARM |
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | No | AB | 075765 | TEVA |
| ROCALTROL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription | Yes | AB | 018044 | SS PHARMA |
CAPSULE;ORAL; 0.5MCG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 203289 | AMNEAL PHARMS |
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 091174 | BIONPHARMA |
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 091356 | STRIDES PHARMA |
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 204556 | SUN PHARM |
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 075765 | TEVA |
| ROCALTROL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription | Yes | AB | 018044 | SS PHARMA |