Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216814
Company: ASCENT PHARMS INC
Company: ASCENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN AND FAMOTIDINE | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG | 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 |
---|---|---|---|---|---|---|---|
03/15/2023 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
11/20/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
IBUPROFEN AND FAMOTIDINE
TABLET;ORAL; 26.6MG;800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE; IBUPROFEN | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG | TABLET;ORAL | Prescription | No | AB | 203658 | ENDO OPERATIONS |
IBUPROFEN AND FAMOTIDINE | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG | TABLET;ORAL | Prescription | No | AB | 211890 | ALKEM LABS LTD |
IBUPROFEN AND FAMOTIDINE | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG | TABLET;ORAL | Prescription | No | AB | 216814 | ASCENT PHARMS INC |
IBUPROFEN AND FAMOTIDINE | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG | TABLET;ORAL | Prescription | No | AB | 211278 | TEVA PHARMS USA |