Drugs@FDA: FDA-Approved Drugs
Company: KING PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INTAL | CROMOLYN SODIUM | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/28/1982 | 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 |
---|---|---|---|---|---|
02/11/2004 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18596slr030ltr.pdf | |
03/06/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/2002 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
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02/26/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/18/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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08/09/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/15/1988 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/18/1993 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/18/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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11/28/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/29/1986 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/05/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/05/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/30/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/19/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/31/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/20/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/27/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/27/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
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10/11/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/11/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf |