Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090619
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;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 |
---|---|---|---|---|---|---|---|
07/08/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/090619Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/20/2015 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 38MG;200MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL PM | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | Yes | 021394 | HALEON US HOLDINGS |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 216204 | AUROBINDO PHARMA |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 090619 | DR REDDYS LABS LTD |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 079113 | PERRIGO R AND D |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 211404 | PLD ACQUISITIONS LLC |