Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201022
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | AB | No | No |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | AB | No | No |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/12/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2023 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/25/2019 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
07/25/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/30/2013 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/30/2013 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
FAMCICLOVIR
TABLET;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |