Drugs@FDA: FDA-Approved Drugs
Company: KING PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORABID | LORACARBEF | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LORABID | LORACARBEF | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1991 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/29/2000 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/27/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 11/08/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1999 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/05/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 11/26/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1996 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/15/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/25/1996 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/13/1996 | SUPPL-13 | Efficacy-New Patient Population |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050667ap.pdf |
| 01/25/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/14/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/22/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1993 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 03/30/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |