Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019722
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NASCOBAL | CYANOCOBALAMIN | 0.5MG/INH | GEL, METERED;NASAL | 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 |
---|---|---|---|---|---|---|---|
11/05/1996 | 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 |
---|---|---|---|---|---|
08/21/2003 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19722slr006ltr.pdf | |
06/14/2002 | SUPPL-4 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19722s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019722_S004_NASCOBAL GEL.pdf |
05/04/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/21/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf |