Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075998
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Discontinued | None | No | No |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 300MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
11/29/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75998APltrF.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2019 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
10/24/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/18/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |