Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019660
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TILADE | NEDOCROMIL SODIUM | 1.75MG/INH | AEROSOL, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 02/11/2004 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19660slr017ltr.pdf |
| 01/30/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
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| 02/26/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/20/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/04/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/20/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/01/1994 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/16/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/27/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/27/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/03/1994 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/19/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1993 | SUPPL-1 | Efficacy-Accelerated Approval Confirmatory Study |
Label is not available on this site. |