SMB Corporation of India · 66-41 · INDIA
For SMB Corporation of India, import alert is 66-41; country is INDIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product code is 65 J - - 36 Intrauterine Copper (Progestin) | 85 H - - DT Device, Intrauterine, Contraceptive and Introducer; date published is 09/30/2009; address is 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA, verified against its source on 2026-10-01.
- Firm
- SMB Corporation of India 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
- 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA verified
- Date published
- 09/30/2009 verified
- Product code
- 65 J - - 36 Intrauterine Copper (Progestin) | 85 H - - DT Device, Intrauterine, Contraceptive and Introducer each item verified
- FDA notes
- 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) | 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) each item verified
What the source says
SMB Corporation of India Date Published : 09/30/2009 13 34 35 Prem Industrial Estate , Gupha Road , Mumbai, Maharashtra INDIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
65 J - - 36 Intrauterine Copper (Progestin) Date Published: 09/30/2009 Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502) 85 H - - DT Device, Intrauterine, Contraceptive and Introducer Date Published: 09/30/2009 Notes: 5/28/2008 All Models Intrauterine Device (IUD) Copper T. IUDS for the purpose of contraception are regulated as medical devices; however; IUDs for the purpose of contraception that incorporate heavy metals; such as copper; drugs; or otherwise active substances are regulated as drugs. The SMB IUDS are new drugs requiring approval applications (see 21 CFR 310.502)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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