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Digital content

08 Jan 2026
// INDPHARMAPOST
https://www.indianpharmapost.com/news/wockhardt-files-marketing-authorisation-application-for-wck-5222-with-ema-18814

01 Dec 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-accepts-wockhardts-nda-for-breakthrough-antibiotic-zaynich/articleshow/125696758.cms

17 Oct 2025
// PHARMABIZ

05 Oct 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/drug-approval/wockhardt-submits-nda-to-usfda-for-zidebactam-cefepime-injection-17932

01 Oct 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/drug-approval/wockhardt-submits-drug-application-to-fda-for-zidebactam-cefepime-for-treatment-of-serious-gram-negative-infections-17923

30 Sep 2025
// PHARMABIZ
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-16
Pay. Date : 2013-05-09
DMF Number : 11935
Submission : 1996-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 1998-053 - Rev 04
Issue Date : 2017-03-21
Type : Chemical
Substance Number : 20
Status : Valid
Registration Number : 303MF10152
Registrant's Address : Wockhardt Towers, Bandra-kurla Complex, Bandra (East), Mumbai-400 051, Maharashtra, India
Initial Date of Registration : 2021-09-28
Latest Date of Registration :
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2022-01-27
Registration Number : 20210112-209-J-507(2)
Manufacturer Name : Wockhardt Ltd
Manufacturer Address : Plot No. 138, Ankleshwar-393 002, Dist. Bharuch, Gujarat State, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-01
Pay. Date : 2015-11-23
DMF Number : 20071
Submission : 2007-05-15
Status : Active
Type : II
Certificate Number : R1-CEP 2008-258 - Rev 02
Issue Date : 2022-05-24
Type : Chemical
Substance Number : 1486
Status : Valid
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20095
Submission : 2006-12-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-234 - Rev 00
Issue Date : 2014-03-07
Type : Chemical
Substance Number : 2131
Status : Valid
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8028
Submission : 1989-04-24
Status : Active
Type : II
Certificate Number : R1-CEP 1998-052 - Rev 04
Issue Date : 2014-06-24
Type : Chemical
Substance Number : 1079
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16650
Submission : 2003-06-16
Status : Active
Type : II
Certificate Number : R1-CEP 2002-203 - Rev 01
Issue Date : 2011-05-23
Type : Chemical
Substance Number : 991
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15411
Submission : 2001-05-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-051 - Rev 01
Issue Date : 2009-12-17
Type : Chemical
Substance Number : 1300
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19385
Submission : 2006-03-01
Status : Active
Type : II
Certificate Number : R0-CEP 2011-211 - Rev 00
Issue Date : 2012-10-15
Type : Chemical
Substance Number : 2574
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24781
Submission : 2011-06-23
Status : Active
Type : II
Certificate Number : R0-CEP 2012-149 - Rev 00
Issue Date : 2014-07-15
Type : Chemical
Substance Number : 2416
Status : Withdrawn by Holder

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-01
Pay. Date : 2015-11-23
DMF Number : 20071
Submission : 2007-05-15
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20439
Submission : 2007-04-06
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18073
Submission : 2005-02-11
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-08-26
Pay. Date : 2013-02-19
DMF Number : 26743
Submission : 2013-02-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14480
Submission : 1999-10-14
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16268
Submission : 2002-11-25
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16119
Submission : 2002-08-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8028
Submission : 1989-04-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16839
Submission : 2003-09-09
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16794
Submission : 2003-08-28
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Approval Date : 2019-02-27
Application Number : 208380
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AP1
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Approval Date : 2023-04-18
Application Number : 205746
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1

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RLD : No
TE Code :
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Dosage Form : TABLET; ORAL
Proprietary Name : PROPOXYPHENE NAPSYLATE A...
Dosage Strength : 325MG;50MG
Approval Date : 2007-03-16
Application Number : 77677
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Dosage Form : TABLET; ORAL
Proprietary Name : PROPOXYPHENE NAPSYLATE A...
Dosage Strength : 650MG;100MG
Approval Date : 2007-03-16
Application Number : 77677
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETIC ACID, GLACIAL; HYDROCORTISONE
Dosage Form : SOLUTION/DROPS; OTIC
Proprietary Name : HYDROCORTISONE AND ACETI...
Dosage Strength : 2%;1%
Approval Date : 1996-08-30
Application Number : 40168
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ADENOSINE
Dosage Strength : 3MG/ML
Approval Date :
Application Number : 79147
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ADENOSINE
Dosage Strength : 3MG/ML
Approval Date : 2009-07-20
Application Number : 90220
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION
Proprietary Name : ALBUTEROL SULFATE
Dosage Strength : EQ 0.083% BASE
Approval Date : 1999-11-22
Application Number : 75394
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ALFUZOSIN HYDROCHLORIDE
Dosage Strength : 10MG
Approval Date : 2012-08-10
Application Number : 90221
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : AMINOPHYLLINE
Dosage Strength : 105MG/5ML
Approval Date : 1983-12-05
Application Number : 88156
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Tablet
Dosage Strength : 75mg
Packaging :
Brand Name : Acetylsalicylic Acid Pinewood
Approval Date : 2024-03-25
Application Number : 20230228000139
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Suspended
Registration Country : Malta
Dosage Form : Gastro-Resistant Tablet
Dosage Strength : 75MG
Packaging :
Brand Name : Aspirin
Approval Date : 2006-05-26
Application Number :
Regulatory Info : Suspended
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Tablet
Dosage Strength : 800MG
Packaging :
Brand Name : Aciclovir
Approval Date : 2006-08-18
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Suspended
Registration Country : Malta
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Brand Name : Aciclovir
Approval Date : 2018-11-09
Application Number :
Regulatory Info : Suspended
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Solution For Injection
Dosage Strength : 3MG
Packaging :
Brand Name : Adenosine
Approval Date : 2017-11-01
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Solution For Infusion
Dosage Strength : 3MG
Packaging :
Brand Name : Adenosine
Approval Date : 2017-11-01
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Brand Name : Allopurinol
Approval Date : 2006-08-18
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Tablet
Dosage Strength : 300MG
Packaging :
Brand Name : Allopurinol
Approval Date : 2006-08-18
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Brand Name : Amiloride
Approval Date : 2006-08-18
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Amiloride Hydrochloride; Furosemide
Dosage Form : Tablet
Dosage Strength : 5.68MG; 40MG
Packaging :
Brand Name : Co-Amilofruse
Approval Date : 2006-08-18
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Wockhardt is a supplier offers 82 products (APIs, Excipients or Intermediates).
Find a price of Dextromethorphan Hydrobromide bulk with DMF, CEP, JDMF, WC offered by Wockhardt
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