Drugs@FDA: FDA-Approved Drugs
Company: LNK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 200MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/01/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75139ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/075139_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/13/2020 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/04/2005 | SUPPL-8 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/075139_S008_IBUPROFEN TABLETS.pdf | |
07/19/2004 | SUPPL-7 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075139_S007_IBUPROFEN TABLETS.pdf | |
02/04/2003 | SUPPL-6 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S006_IBUPROFEN TABLETS.pdf | |
08/05/2003 | SUPPL-5 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075139_S005_IBUPROFEN TABLETS.pdf | |
08/15/2002 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S004_IBUPROFEN TABLETS.pdf |
02/11/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf |
02/11/2002 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075139_S002&S003_IBUPROFEN TABLETS.pdf |
08/15/2001 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075139_S001_IBUPROFEN_TABLETS.pdf |
IBUPROFEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 018989 | HALEON US HOLDINGS |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079233 | AMNEAL PHARMS |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071333 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072199 | AMNEAL PHARMS NY |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 208865 | AUROBINDO PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076460 | AVEMA PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072299 | CONTRACT PHARMACAL |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075661 | DR REDDYS LA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076117 | DR REDDYS LABS INC |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071229 | ENDO OPERATIONS |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 202312 | GRANULES |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079174 | GRANULES INDIA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075010 | LNK |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075139 | LNK |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091237 | MARKSANS PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091239 | MARKSANS PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 073019 | MCNEIL |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072096 | PERRIGO |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 077349 | PERRIGO R AND D |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207095 | SHANDONG XINHUA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 070481 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079129 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091355 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 206989 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207052 | STRIDES PHARMA |
MOTRIN IB | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 019012 | J AND J CONSUMER INC |