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
ACYCLOVIR از شرکت ALEMBIC PHARMS LTD
Abbreviated New Drug Application (ANDA): 209000
Company: ALEMBIC PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
04/06/2018 | 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 |
---|---|---|---|---|---|
07/12/2019 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
ACYCLOVIR
OINTMENT;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 209000 | ALEMBIC PHARMS LTD |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 204605 | AMNEAL PHARMS |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 210774 | APOTEX |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205974 | CADILA |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 211794 | CIPLA |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205591 | COSETTE |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 206633 | FOUGERA PHARMS INC |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205510 | GLENMARK PHARMS SA |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 212444 | MACLEODS PHARMS LTD |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 202459 | MYLAN PHARMS INC |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 212495 | SOLARIS PHARMA CORP |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205469 | TARO |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 209971 | TORRENT |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 201501 | XIROMED |
ZOVIRAX | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | Yes | AB | 018604 | BAUSCH |
منبع : www.accessdata.fda.gov
نظرات کاربران