Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018887
Company: KING PHARMS LLC
Company: KING PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INTAL | CROMOLYN SODIUM | 0.8MG/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 |
---|---|---|---|---|---|---|---|
12/05/1985 | 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 |
---|---|---|---|---|---|
02/11/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18887slr020ltr.pdf | |
07/23/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/27/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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12/21/1995 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/25/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
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04/15/1988 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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01/31/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/31/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
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-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf |