Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075067
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/19/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75067ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74706ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/20/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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04/03/2001 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/28/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/28/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |