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
CRYSELLE از شرکت DURAMED PHARMS BARR
Abbreviated New Drug Application (ANDA): 075840
Company: DURAMED PHARMS BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-21 | Prescription |
AB |
No | No |
| CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75840.ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-25 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
CRYSELLE
TABLET;ORAL-21; 0.03MG;0.3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-21 | Prescription | No | AB | 075840 | DURAMED PHARMS BARR |
TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 075840 | DURAMED PHARMS BARR |
| ELINEST | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 091105 | NOVAST LABS LTD |
| LOW-OGESTREL-28 | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 075288 | MAYNE PHARMA |
منبع : www.accessdata.fda.gov
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