Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212718
Company: HERITAGE PHARMS INC
Company: HERITAGE PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ACYCLOVIR
SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 074738 | ACTAVIS MID ATLANTIC |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 077026 | AKORN |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 216331 | AUROBINDO PHARMA LTD |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212718 | HERITAGE PHARMS INC |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212252 | NOVITIUM PHARMA |
| ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 213951 | VISTAPHARM |
| ZOVIRAX | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 019909 | MYLAN |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English