اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CALCITRIOL از شرکت TEVA
Abbreviated New Drug Application (ANDA): 075765
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCITRIOL | CALCITRIOL | 0.25MCG | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CALCITRIOL | CALCITRIOL | 0.5MCG | CAPSULE;ORAL | Prescription |
AB |
No | 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 |
|---|---|---|---|---|---|---|---|
| 10/12/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75765.ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/21/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/16/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
CALCITRIOL
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 INC |
| 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 | VALIDUS PHARMS |
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 INC |
| 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 | VALIDUS PHARMS |
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