Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPCON-A | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | Yes | 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 |
---|---|---|---|---|---|---|---|
06/08/1994 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/23/2022 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020065Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020065Orig1s033ltr.pdf | |
03/14/2016 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/18/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/12/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020065s017ltr.pdf | |
12/18/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/23/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
07/23/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
05/09/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
04/20/2005 | SUPPL-10 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020065s010ltr.pdf |
03/13/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/11/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/1995 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/29/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/29/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/11/1994 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/23/2022 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020065Orig1s033lbl.pdf | |
07/31/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf |
OPCON-A
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION/DROPS;OPHTHALMIC; 0.02675%;0.315%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 078208 | ALTAIRE PHARMS INC |
OPCON-A | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 020065 | BAUSCH AND LOMB |