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1. 903576-44-3
2. Ciproxidine
3. Bf 2649
4. Pitolisant Hcl
5. Pitolisant (hydrochloride)
6. Bf 2649 Hydrochloride
7. Yv33ch63hi
8. Pitolisant Hydrochloride [usan]
9. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Hydrochloride
10. Piperidine, 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-, Hydrochloride
11. 903576-44-3 (hcl)
12. Wakix (tn)
13. Pitolisant Hydrochloride (usan)
14. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine Hydrochloride
15. 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine Hydrochloride
16. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride
17. Bf 2.649
18. Unii-yv33ch63hi
19. Schembl4591893
20. Bf-2649 Hydrochloride
21. Chembl4164059
22. Dtxsid50238098
23. Pitolisant;ciproxidine; Bf2649
24. Amy23423
25. Bcp16427
26. Ex-a1420
27. Hy-12199b
28. Pitolisant Hydrochloride [mi]
29. S5926
30. Akos024457784
31. Cs-1501
32. Sb17036
33. Pitolisant Hydrochloride [who-dd]
34. Ac-36017
35. As-72196
36. A3727
37. Pitolisant Hydrochloride [orange Book]
38. C77058
39. D11490
40. A900088
41. Q27895485
42. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine;hydrochloride
43. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Monohydrochloride
44. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride (1:1)
Molecular Weight | 332.3 g/mol |
---|---|
Molecular Formula | C17H27Cl2NO |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 8 |
Exact Mass | 331.1469699 g/mol |
Monoisotopic Mass | 331.1469699 g/mol |
Topological Polar Surface Area | 12.5 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 235 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
NDC Package Code : 73435-034
Start Marketing Date : 2023-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
NDC Package Code : 70966-0038
Start Marketing Date : 2019-08-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
Type : II
NDC Package Code : 14501-0114
Start Marketing Date : 2023-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2026-02-06
Exclusivity Code : NCE
Exclusivity Expiration Date : 2024-08-14
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-255
Exclusivity Expiration Date : 2026-08-14
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-331
Exclusivity Expiration Date : 2027-10-13
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-21
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-489
Exclusivity Expiration Date : 2031-06-21
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2024-08-14
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-255
Exclusivity Expiration Date : 2026-08-14
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-331
Exclusivity Expiration Date : 2027-10-13
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-21
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-489
Exclusivity Expiration Date : 2031-06-21
Application Number : 211150
Product Number : 2
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