Drugs@FDA: FDA-Approved Drugs
Company: OHM LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROHM COLD AND SINUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74567ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/074567.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/09/2012 | SUPPL-29 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/09/2012 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/09/2012 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 08/18/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/27/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/22/2006 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/19/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/13/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/17/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/17/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/17/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/2002 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/31/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
IBUPROHM COLD AND SINUS
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 |