ACYCLOVIR از شرکت MACLEODS PHARMS LTD
Abbreviated New Drug Application (ANDA): 212444
Company: MACLEODS 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 |
|---|---|---|---|---|---|---|---|
| 05/19/2021 | 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 |
|---|---|---|---|---|---|
| 08/05/2021 | 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
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