Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075203
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/24/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75203_Propafenone%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075203_propafenone-hydrochloride_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/13/2019 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/13/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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08/13/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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09/24/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/07/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/24/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/19/2002 | 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 |
---|---|---|---|---|---|
10/24/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75203_Propafenone%20Hydrochloride_Prntlbl.pdf |
PROPAFENONE HYDROCHLORIDE
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 076550 | ANI PHARMS |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 202445 | AUROBINDO PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 075938 | STRIDES PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 075203 | WATSON LABS |
TABLET;ORAL; 225MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 076550 | ANI PHARMS |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 202445 | AUROBINDO PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 075938 | STRIDES PHARMA |
PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | TABLET;ORAL | Prescription | No | AB | 075203 | WATSON LABS |