Gopaldas Visram & Company Ltd. · 66-41 · INDIA
For Gopaldas Visram & Company Ltd. · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Vagisten-V; Miconazole Nitrate Vaginal Cream | Vagisten-V; Miconazole Nitrate Vaginal Cream | Super Apeti Plus Syrup | Vagisten-V; Miconazole Nitrate Vaginal Cream; product code is 56 G - - 99 Antifungal N.E.C. | 61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/16/2019; address is A/327, TTC Industrial Area, MIDC Mahape , Navi Mumbai, Maharashtra INDIA, verified against its source on 2026-09-16.
- Firm
- Gopaldas Visram & Company Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- INDIA verified
- Address
- A/327, TTC Industrial Area, MIDC Mahape , Navi Mumbai, Maharashtra INDIA verified
- Date published
- 08/16/2019 verified
- Product code
- 56 G - - 99 Antifungal N.E.C. | 61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Vagisten-V; Miconazole Nitrate Vaginal Cream | Vagisten-V; Miconazole Nitrate Vaginal Cream | Super Apeti Plus Syrup | Vagisten-V; Miconazole Nitrate Vaginal Cream each item verified
- FDA notes
- “Super Apeti Plus Syrup” appears to be a “new drug” as defined by section 201(p) of the FD&C Act, because it is not generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the FD&C Act. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA-approved applications in effect for “Super Apeti Plus Syrup.” Therefore, its introduction and delivery for introduction into interstate commerce appears to violate section 505(a) of the FD&C Act. verified
What the source says
Gopaldas Visram & Company Ltd. Date Published : 08/16/2019 A/327, TTC Industrial Area, MIDC Mahape , Navi Mumbai, Maharashtra INDIA 56 G - - 99 Antifungal N.E.C. Date Published: 08/16/2019 Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream 61 W - - 18 Miconazole Nitrate (Anti-Fungal) (Not Antibiotic) Date Published: 08/16/2019 Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) Date Published: 11/16/2021 Desc: Super Apeti Plus Syrup Notes: “Super Apeti Plus Syrup” appears to be a “new drug” as defined by section 201(p) of the FD&C Act, because it is not generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the FD&C Act. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA-approved applications in effect for “Super Apeti Plus Syrup.” Therefore, its introduction and delivery for introduction into interstate commerce appears to violate section 505(a) of the FD&C Act. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/16/2019 Desc: Vagisten-V; Miconazole Nitrate Vaginal Cream
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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