Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REGONOL | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/14/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
04/05/2021 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017398Orig1s025ltr.pdf |
05/18/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/21/2004 | SUPPL-15 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17398s015ltr.pdf | |
10/17/2003 | SUPPL-14 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17398scm014ltr.pdf |
07/12/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/15/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/28/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/06/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/05/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/30/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/10/1987 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/05/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/18/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/18/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/13/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/13/1980 | 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 |
---|---|---|---|---|---|
09/21/2004 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf |
REGONOL
INJECTABLE;INJECTION; 5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESTINON | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 009830 | BAUSCH |
REGONOL | PYRIDOSTIGMINE BROMIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 017398 | SANDOZ |