Drugs@FDA: FDA-Approved Drugs
Company: JOHNSON AND JOHNSON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VISINE L.R. | OXYMETAZOLINE HYDROCHLORIDE | 0.025% | 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 |
---|---|---|---|---|---|---|---|
03/31/1989 | 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 |
---|---|---|---|---|---|
11/01/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19407slr010ltr.pdf |
01/11/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/10/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/15/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/17/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/05/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1995 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
02/13/1990 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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10/27/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
VISINE L.R.
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; 0.025%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
VISINE L.R. | OXYMETAZOLINE HYDROCHLORIDE | 0.025% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 019407 | JOHNSON AND JOHNSON |