Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208702
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/04/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208702Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208702Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2021 | SUPPL-2 | Labeling-Patient Package Insert, 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 | 212361 | ALEMBIC |
ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 208766 | AMNEAL |
ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 208702 | PADAGIS ISRAEL |
ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 205470 | TARO |
ACYCLOVIR | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | No | AB | 206770 | ZYDUS LIFESCIENCES |
ZOVIRAX | ACYCLOVIR | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 021478 | BAUSCH |