Drugs@FDA: FDA-Approved Drugs
Company: ABBOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORVIR | RITONAVIR | 100MG | 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 |
---|---|---|---|---|---|---|---|
03/01/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/09/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
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04/12/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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04/29/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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05/26/1999 | SUPPL-11 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm | |
02/12/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/21/1998 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020680_S009_NORVIR.pdf |
10/31/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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09/12/1997 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/11/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/08/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/24/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/01/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/01/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |