Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020463
Company: BLACKSMITH BRANDS
Company: BLACKSMITH BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NASALCROM | CROMOLYN SODIUM | 5.2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/03/1997 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | 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 |
|---|---|---|---|---|---|
| 07/15/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20463s008ltr.pdf |
| 11/27/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2001 | SUPPL-2 | Efficacy-New Patient Population |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20463S2LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-463S002_NasalCrom.cfm |
| 11/04/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |