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
CAFFEINE CITRATE از شرکت MICRO LABS
Abbreviated New Drug Application (ANDA): 207400
Company: MICRO LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 12/14/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/12/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2020 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CAFFEINE CITRATE
SOLUTION;INTRAVENOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAFCIT | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020793 | HIKMA |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077906 | AM REGENT |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205013 | EUGIA PHARMA |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077233 | EXELA PHARMA SCIENCE |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077997 | FRESENIUS KABI USA |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207400 | MICRO LABS |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090827 | SAGENT PHARMS |
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