ACYCLOVIR از شرکت AMNEAL
Abbreviated New Drug Application (ANDA): 208766
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 5% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 11/09/2020 | 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 |
|---|---|---|---|---|---|
| 11/01/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ACYCLOVIR
CREAM;TOPICAL; 5%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 208766 | AMNEAL |
| ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 208702 | PADAGIS ISRAEL |
| ZOVIRAX | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 021478 | BAUSCH |
حتما بخوانید : ACYCLOVIR از شرکت SQUARE PHARMS LTD
منبع : www.accessdata.fda.gov
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