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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Astrazeneca to the U.S. FDA. Original Data : FDA Website

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01 ACYCLOVIR USP, BULK (1)

02 ALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBO (1)

03 ATENOLOL (1)

04 ATENOLOL ACETATE (1)

05 ATENOLOL BULK DRUG (1)

06 AZD2292 (1)

07 BUDESONIDE (1)

08 CHLORHEXIDINE GLUCONATE 20% SOLUTION B.P. (1)

09 COSMOCIL CQ (POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE) (1)

10 DIPRIVAN (1)

11 EXENDIN-4 INJECTION DRUG PRODUCT (1)

12 FACILITIES AND CONTROLS AT THE WESTBORO, MASS LOCATION (1)

13 FOSCARNET SODIUM INTRAVENOUS SOLUTION (1)

14 GOSERELIN ACETATE (1)

15 GOSERELIN ACETATE IMPLANT (1)

16 HALOTHANE (1)

17 HUMANIZED MONOCLONAL ANTIBODY (HULM609) TO HUMAN VITRONECTIN RECEPTOR (1)

18 HUMANIZED MONOCLONAL ANTIBODY (MEDI-522) TO THE VITRONECTIN (ALPHA-5 BETA-3) RECEPTOR (1)

19 LEUKOTRIENES (1)

20 LISINOPRIL BULK DRUG (1)

21 LISINOPRIL DIHYDRATE (1)

22 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SODERTALFE, SWEDEN. (1)

23 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SODERTALJE. (1)

24 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

25 METOPROLOL SUCCINATE EXTENDED RELEASE TABLETS (1)

26 METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE 25/12.5,50/12.5 AND100/12.5 TABLETS (1)

27 OMEPRAZOLE CAPSULES (1)

28 OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE (1)

29 POLYOXYETHYLENE FAT. ACID ESTERS (1)

30 PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM) (1)

31 SDM 70 (1)

32 SDM-70 NITROGLYCERIN/POLYMER MIXTURE (1)

33 SIPLIZUMAB [HUMANIZED MONOCLONAL ANTIBODY (MEDI-507) (NSO CELLS, MEDIMMUNE) TO CD2] (1)

34 TCV-116 (1)

35 TERBUTALINE SULPHATE (1)

36 TOCAINIDE HCL. INJECTION (1)

37 ZESTRIL (LISINOPRIL) TABLETS (1)

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01 AB ASTRA (3)

02 AMYLIN PHARMACEUTICALS INC (1)

03 ASTRA CLINICAL RESEARCH ASSOC INC (1)

04 ASTRA IDL LTD (1)

05 ASTRA MERCK INC (1)

06 ASTRA PHARMACEUTICAL PRODUCTS INC (1)

07 ASTRA RESEARCH LABORATORIES (1)

08 ASTRA USA INC (2)

09 ASTRAZENECA AB (2)

10 ASTRAZENECA PHARMACEUTICAL LP (1)

11 ASTRAZENECA PHARMACEUTICALS LP (8)

12 IPR PHARMACEUTICALS INC (1)

13 MEDIMMUNE INC (2)

14 MEDIMMUNE LLC (1)

15 PEARL THERAPEUTICS INC (1)

16 ZENECA INC (3)

17 ZENECA PHARMACEUTICALS (6)

18 ZENECA PHARMACEUTICALS DIV ZENECA INC (1)

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01 U.S.A (3)

02 United Kingdom (34)

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01 Active (8)

02 Inactive (29)

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01 Blank (37)

URL Supplier Web Content
ASTRA IDL LTD
Inactive
15099
N/A
2000-10-18
II
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PEARL THERAPEUTICS IN...
Active
31995
N/A
2017-10-06
II
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ASTRAZENECA PHARMACEU...
Inactive
6905
N/A
1987-03-30
II
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ASTRAZENECA PHARMACEU...
Inactive
7101
N/A
1987-08-06
II
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IPR PHARMACEUTICALS I...
Inactive
12149
N/A
1996-10-07
II
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ASTRAZENECA PHARMACEU...
Active
33171
N/A
2018-10-10
II
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ZENECA PHARMACEUTICAL...
Inactive
3003
N/A
1977-08-12
II
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ZENECA PHARMACEUTICAL...
Inactive
8915
N/A
1991-01-04
II
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AMYLIN PHARMACEUTICAL...
Inactive
13157
N/A
1998-08-27
II
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ASTRA CLINICAL RESEAR...
Inactive
6036
N/A
1985-10-02
II
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