Synopsis
Synopsis
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CEP/COS
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JDMF
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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Molecular Weight | 292.5 g/mol |
---|---|
Molecular Formula | C10H8Cl3N3O |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 1 |
Rotatable Bond Count | 0 |
Exact Mass | 290.973295 g/mol |
Monoisotopic Mass | 290.973295 g/mol |
Topological Polar Surface Area | 44.7 A^2 |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 360 |
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 |
1 of 4 | |
---|---|
Drug Name | Agrylin |
PubMed Health | Anagrelide (By mouth) |
Drug Classes | Platelet Reducing Agent |
Drug Label | Name: AGRYLIN (anagrelide hydrochloride)Dosage Form:0.5 mg capsules for oral administrationActive Ingredient:AGRYLIN Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).Inactive Ingredients:Anhydrous Lactose NF, Crospov... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base |
Market Status | Prescription |
Company | Shire |
2 of 4 | |
---|---|
Drug Name | Anagrelide hydrochloride |
Drug Label | Anagrelide hydrochloride is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide hydrochloride is a platelet-reducing agent with a chemical name of 6,7-dichloro-1,... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base; eq 1mg base |
Market Status | Prescription |
Company | Mylan Pharms; Ivax Sub Teva Pharms; Mylan; Impax Labs; Barr |
3 of 4 | |
---|---|
Drug Name | Agrylin |
PubMed Health | Anagrelide (By mouth) |
Drug Classes | Platelet Reducing Agent |
Drug Label | Name: AGRYLIN (anagrelide hydrochloride)Dosage Form:0.5 mg capsules for oral administrationActive Ingredient:AGRYLIN Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).Inactive Ingredients:Anhydrous Lactose NF, Crospov... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base |
Market Status | Prescription |
Company | Shire |
4 of 4 | |
---|---|
Drug Name | Anagrelide hydrochloride |
Drug Label | Anagrelide hydrochloride is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide hydrochloride is a platelet-reducing agent with a chemical name of 6,7-dichloro-1,... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base; eq 1mg base |
Market Status | Prescription |
Company | Mylan Pharms; Ivax Sub Teva Pharms; Mylan; Impax Labs; Barr |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16440
Submission : 2003-02-25
Status : Active
Type : II
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17041
Submission : 2003-12-16
Status : Active
Type : II
NDC Package Code : 63818-0425
Start Marketing Date : 2017-07-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-23
Pay. Date : 2022-06-08
DMF Number : 37180
Submission : 2022-06-01
Status : Active
Type : II
NDC Package Code : 42571-413
Start Marketing Date : 2022-03-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-02
Pay. Date : 2015-06-30
DMF Number : 29475
Submission : 2015-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16024
Submission : 2002-06-24
Status : Active
Type : II
Date of Issue : 2022-06-20
Valid Till : 2025-08-08
Written Confirmation Number : WC-0113
Address of the Firm :
NDC Package Code : 53104-7537
Start Marketing Date : 2018-07-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.4kg/.4kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Phambio Co., Ltd.
Registration Date : 2018-11-14
Registration Number : No. 4838-7-ND(2)
Manufacturer Name : Cipla Limited
Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, INDIA
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-14
Pay. Date : 2014-06-11
DMF Number : 16531
Submission : 2003-03-30
Status : Active
Type : II
NDC Package Code : 65841-106
Start Marketing Date : 2024-09-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38181
Submission : 2023-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15971
Submission : 2002-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16969
Submission : 2003-11-12
Status : Inactive
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16440
Submission : 2003-02-25
Status : Active
Type : II
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17041
Submission : 2003-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16969
Submission : 2003-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15971
Submission : 2002-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16024
Submission : 2002-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-23
Pay. Date : 2022-06-08
DMF Number : 37180
Submission : 2022-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38181
Submission : 2023-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-02
Pay. Date : 2015-06-30
DMF Number : 29475
Submission : 2015-07-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-14
Pay. Date : 2014-06-11
DMF Number : 16531
Submission : 2003-03-30
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18240
Submission : 2005-02-25
Status : Inactive
Type : II
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