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
CALCIUM ACETATE از شرکت HIKMA
Abbreviated New Drug Application (ANDA): 077728
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CALCIUM ACETATE
CAPSULE;ORAL; 667MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 201658 | AMNEAL PHARMS |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 091312 | CHARTWELL RX |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 202315 | HERITAGE PHARMS INC |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 077728 | HIKMA |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 203135 | INVAGEN PHARMS |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 202127 | LUPIN LTD |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 203179 | NOSTRUM LABS INC |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 211038 | SUVEN PHARMS |
| PHOSLO GELCAPS | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | Yes | AB | 021160 | FRESENIUS MEDCL |
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