Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074727
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074727_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2009 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/21/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/13/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/08/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |