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07-11 July, 2025
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08-09 July, 2025
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07-11 July, 2025
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Industry Trade Show
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08-09 July, 2025
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08 Apr 2025
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26 Aug 2024
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25 Jun 2024
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07 Feb 2024
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16 Jan 2024
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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208443
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-18
DMF Number : 30553
Submission : 2016-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25134
Submission : 2011-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3946
Submission : 1980-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30635
Submission : 2016-07-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22983
Submission : 2009-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8053
Submission : 1989-05-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10643
Submission : 1993-12-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3681
Submission : 1979-12-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3687
Submission : 1979-12-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14653
Submission : 2000-01-03
Status : Inactive
Type : II
JDMF
Registration Number : 220MF10258
Registrant's Address : 201/301, Corporate Enclave, HDO-Corporate Building, Wing'B', B. D. Sawant Marg, Chaka...
Initial Date of Registration : 2008-12-22
Latest Date of Registration : 2008-12-22
NDC Package Code : 0591-3955
Start Marketing Date : 2018-04-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (50mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Details:
Under the licensing agreement, Lotus will holds the rights of LNZ100 (Aceclidine HCl) in Korea, which is being evaluated for the treatment of Presbyopia.
Lead Product(s): Aceclidine Hydrochloride,Brimonidine Tartrate
Therapeutic Area: Ophthalmology Brand Name: LNZ100
Study Phase: Phase IIIProduct Type: Other Small Molecule
Recipient: LENZ Therapeutics
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 09, 2025
Lead Product(s) : Aceclidine Hydrochloride,Brimonidine Tartrate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Recipient : LENZ Therapeutics
Deal Size : $125.0 million
Deal Type : Licensing Agreement
LENZ and Lotus Sign License Deal for LNZ100 in Korea and Southeast Asia
Details : Under the licensing agreement, Lotus will holds the rights of LNZ100 (Aceclidine HCl) in Korea, which is being evaluated for the treatment of Presbyopia.
Product Name : LNZ100
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
May 09, 2025
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET, DELAYED RELEASE;...
Brand Name : CAMPRAL
Dosage Strength : 333MG **Federal Regist...
Packaging :
Approval Date : 2004-07-29
Application Number : 21431
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 25MG
Packaging :
Approval Date : 2008-05-07
Application Number : 77532
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 50MG
Packaging :
Approval Date : 2008-05-07
Application Number : 77532
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 100MG
Packaging :
Approval Date : 2008-05-07
Application Number : 77532
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Dosage Form : Infusion fluid, resoluti...
Brand Name : Acetaminophen Actavis
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Infusion fluid, resoluti...
Brand Name : Acetaminophen Actavis
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Granules
Brand Name : Pinex
Dosage Strength : 1 g
Packaging : Dose Bag
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Brand Name : Pinex
Dosage Strength : 500 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Brand Name : Pinex
Dosage Strength : 500 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Brand Name : Pinex
Dosage Strength : 500 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Excipients
Inspections and registrations
ABOUT THIS PAGE
Actavis Inc is a supplier offers 47 products (APIs, Excipients or Intermediates).
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