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
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE از شرکت AM REGENT
Abbreviated New Drug Application (ANDA): 090747
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION; 3MG/ML;EQ 3MG BASE/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AB | 090747 | AM REGENT |
| CELESTONE SOLUSPAN | BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | 3MG/ML;EQ 3MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 014602 | ORGANON |
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