Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211890
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/03/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211890Orig1s000ltr.pdf |
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 | PAR PHARM |
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 |