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
CYPROHEPTADINE HYDROCHLORIDE از شرکت HERITAGE PHARMA
Abbreviated New Drug Application (ANDA): 087056
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription |
AA |
No | 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 |
|---|---|---|---|---|---|---|---|
| 01/10/1980 | 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 |
|---|---|---|---|---|---|
| 03/20/2009 | SUPPL-45 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf |
||
| 07/29/2002 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/10/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/12/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/20/2009 | SUPPL-45 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf |
CYPROHEPTADINE HYDROCHLORIDE
TABLET;ORAL; 4MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 206553 | APPCO |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 206676 | BEXIMCO PHARMS USA |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 040644 | BOSCOGEN |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 207555 | ELYSIUM |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 087056 | HERITAGE PHARMA |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 040537 | MOUNTAIN |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 205087 | NOVAST LABS |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 212491 | QUAGEN |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 207783 | RISING |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 209172 | STRIDES PHARMA |
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | No | AA | 208938 | ZYDUS PHARMS |
نظرات کاربران