Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074738
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
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 |
---|---|---|---|---|---|---|---|
04/28/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
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01/24/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
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09/18/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/22/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/13/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/16/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/16/2001 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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07/06/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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03/26/1998 | SUPPL-1 | Labeling |
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 | 216331 | AUROBINDO PHARMA |
ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212718 | CHARTWELL RX |
ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215669 | HETERO LABS LTD III |
ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 217393 | MSN |
ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212252 | NOVITIUM PHARMA |
ACYCLOVIR | ACYCLOVIR | 200MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215724 | RUBICON |