Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077628
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 PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | 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 |
---|---|---|---|---|---|---|---|
08/14/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/04/2015 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/04/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
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;30MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | Yes | 019771 | HALEON US HOLDINGS |
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 077628 | DR REDDYS LABS LTD |
IBUPROHM COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 074567 | OHM LABS |
SINE-AID IB | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET;ORAL | Over-the-counter | No | 019899 | J AND J CONSUMER INC |