01 1Abbott Laboratories
02 1Indoco Remedies Limited
03 1Lusochimica
04 1SMITH & NEPHEW INC
05 2Sifavitor srl
06 3Blank
01 1(S)-BETAXOLOL HYDROCHLORIDE INFO TRANS. TO DMF 5464 ON 9/2/88
02 1BETAXOLOL
03 1BETAXOLOL HCL (NODS)
04 4BETAXOLOL HYDROCHLORIDE
05 1BETAXOLOL HYDROCHLORIDE USP
06 1BETAXOLOL HYDROCHLORIDE, USP
01 1Canada
02 1India
03 3Italy
04 1U.S.A
05 3Blank
01 3Active
02 6Inactive
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12638
Submission : 1997-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25301
Submission : 2011-09-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10727
Submission : 1994-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17235
Submission : 2004-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12680
Submission : 1997-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8662
Submission : 1990-07-19
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7615
Submission : 1988-07-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5464
Submission : 1984-07-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3800
Submission : 1980-05-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Betaxolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaxolol, including repackagers and relabelers. The FDA regulates Betaxolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaxolol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Betaxolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaxolol supplier is an individual or a company that provides Betaxolol active pharmaceutical ingredient (API) or Betaxolol finished formulations upon request. The Betaxolol suppliers may include Betaxolol API manufacturers, exporters, distributors and traders.
click here to find a list of Betaxolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betaxolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Betaxolol active pharmaceutical ingredient (API) in detail. Different forms of Betaxolol DMFs exist exist since differing nations have different regulations, such as Betaxolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betaxolol DMF submitted to regulatory agencies in the US is known as a USDMF. Betaxolol USDMF includes data on Betaxolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betaxolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betaxolol suppliers with USDMF on PharmaCompass.
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