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
CAFCIT از شرکت HIKMA PHARMS
New Drug Application (NDA): 020793
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAFCIT | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
Yes | Yes |
| CAFCIT | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription |
AA |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/21/1999 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020793s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020793Orig1s019ltr.pdf |
||
| 12/23/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2010 | SUPPL-9 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020793s009ltr.pdf |
||
| 03/08/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s4ltr.pdf |
|
| 01/18/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s3ltr.pdf |
|
| 04/14/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-1 | Efficacy-New Route Of Administration |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20793s1ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020793s019lbl.pdf | |
| 06/11/2010 | SUPPL-9 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf | |
| 04/12/2000 | SUPPL-1 |
Efficacy-New Route Of Administration |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf | |
| 09/21/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf |
CAFCIT
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 PHARMS |
| 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 |
SOLUTION;ORAL; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AA
| 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;ORAL | Prescription | Yes | AA | 020793 | HIKMA PHARMS |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 077304 | EXELA PHARMA |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 078002 | FRESENIUS KABI USA |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 213202 | MICRO LABS |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 091102 | SAGENT PHARMS |
| CAFFEINE CITRATE | CAFFEINE CITRATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | SOLUTION;ORAL | Prescription | No | AA | 090357 | SUN PHARM |
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