Drugs@FDA: FDA-Approved Drugs
Company: STAND HOMEOPATH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IVY BLOCK | BENTOQUATAM | 5% | LOTION;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
08/26/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020532Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/02/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/16/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/09/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/03/1998 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/13/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/16/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/04/1996 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
IVY BLOCK
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
LOTION;TOPICAL; 5%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
IVY BLOCK | BENTOQUATAM | 5% | LOTION;TOPICAL | Over-the-counter | Yes | 020532 | STAND HOMEOPATH |