Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215486
Company: MARKSANS PHARMA
Company: MARKSANS PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
08/25/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ACETAMINOPHEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 650MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207229 | AUROBINDO PHARMA |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 211544 | GRANULES |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207035 | HERITAGE PHARMA |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215486 | MARKSANS PHARMA |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076200 | OHM LABS |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075077 | PERRIGO |
ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 078569 | SUN PHARM INDS LTD |
TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 019872 | J AND J CONSUMER INC |