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Astrazeneca Plc's list of EU CTD Dossiers, Marketing Authorizations, In, Out Licensing Opportunities & Finished Dosage Formulations aggregated by PharmaCompass

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ASTRAZENECA

ASTRAZENECA AB

ASTRAZENECA CANADA INC

ASTRAZENECA PHARMS

AstraZeneca PLC

AstraZeneca Pty Ltd

Astrazeneca Pharmaceuticals (Pty) Ltd

Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

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ACALABRUTINIB

ACLIDINIUM BROMIDE

AMITRIPTYLINE HYDROCHLORIDE

ANASTROZOLE

ATENOLOL

Anastrozole

Atenolol

BENRALIZUMAB

BICALUTAMIDE

BRETYLIUM TOSYLATE

BUDESONIDE

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Bicalutamide

Budesonide

CANDESARTAN CILEXETIL

CHLORTHALIDONE

CICLESONIDE

Candesartan

Candesartan Cilexetil

Ciclesonide

DAPAGLIFLOZIN

DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

DEZOCINE

DROPERIDOL

DROPERIDOL; FENTANYL CITRATE

DURVALUMAB

DYCLONINE HYDROCHLORIDE

Dapagliflozin propanediol

Dapaglifozin Propanediol

ENALAPRIL MALEATE; FELODIPINE

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

ESOMEPRAZOLE MAGNESIUM

Esomeprazole

anastrozole

atenolol

benralizumab

bicalutamide

budesonide

budesonide + formoterol (eformoterol)

candesartan

candesartan + hydrochlorothiazide

ciclesonide

dapagliflozin

dapagliflozin + metformin

esomeprazole

esomeprazole (&) clarithromycin (&) amoxicillin

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AEROSOL, METERED DOSE

AEROSOL, METERED;INHALATION

AEROSOL, METERED;NASAL

AQS

CAPSULE

CAPSULE, DELAYED REL PELLETS;ORAL

CAPSULE;ORAL

FILM COATED PILL

FOR SUSPENSION, DELAYED RELEASE;ORAL

Film coated Tablet

GRA

GRANULES FOR SUSPENSION, DELAYED RELEASE

INH

INJ

INJECTABLE;INJECTION

POWDER

POWDER (METERED DOSE)

POWDER, METERED;INHALATION

SLN

SOLUTION

SOLUTION;TOPICAL

SPRAY, METERED DOSE

SPRAY, METERED;NASAL

SUSPENSION

SUSPENSION;INHALATION

TAB

TABLET

TABLET (DELAYED-RELEASE)

TABLET (IMMEDIATE AND DELAYED-RELEASE)

TABLET, EXTENDED RELEASE;ORAL

TABLET; ORAL

TABLET;ORAL

tablet

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0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0.005MG/ML;1%

0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0.005MG/ML;1.5%

0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0.005MG/ML;2%

0.005MG/ML;4%

0.032MG/INH

0.032MG/SPRAY

0.064MG/INH

0.08MG/INH

0.08MG/INH;0.0045MG/INH

0.125MG/ML

0.16MG/INH

0.16MG/INH;0.0045MG/INH

0.25MG/2ML

0.25MG/ML

0.32MG/INH

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0.5MG/2ML

0.5MG/ML

0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1 mg

1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

10 mg

100MCG/ACT

100MG

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

100mcg

100mg

10MG

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

10MG/ML

10MG/SACHET

10MG;1GM

10MG;1GM;EQ 5MG BASE

10MG;500MG

10MG;EQ 5MG BASE

10mg

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

150mg

15MG/ML

16 mg

16 mg + 12.5 mg

160µg

16MG

16mg

1MG

1MG/2ML

1mg

2.5MG/ML

2.5MG/ML;EQ 0.05MG BASE/ML

2.5MG;1GM

2.5MG;1GM;EQ 2.5MG BASE

200MCG/ACT

200mcg

20MG

20mg

25MG

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

25mg

2mg/ml

30MG/ML

32 mg

32 mg + 12.5 mg

32 mg + 25 mg

320µg

32MG

32mcg

32mg

4 mg

400MCG/ACT

400mcg

400mg

40MG

40mg

4MG

4mg/ml

50 mg

50MCG/ACT

50MG

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

50MG/ML

50mg

5MG

5MG/ML

5MG;1GM

5MG;1GM;EQ 2.5MG BASE

5MG;1GM;EQ 5MG BASE

5MG;2.5MG

5MG;500MG

5MG;5MG

5MG;EQ 5MG BASE

5mg

64mcg

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

8 mg

80µg

8MG

8mg

EQ 20MG BASE

EQ 20MG BASE/PACKET

EQ 40MG BASE

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AUSTRALIA

CANADA

SOUTH AFRICA

SWEDEN

USA

CAPSULE;ORAL
100MG
CALQUENCE
USA
210259
2017-10-31
RX
CAPSULE
100MG
CALQUENCE
CANADA
2491788
Prescription
POWDER (METERED DOSE)
400MCG/ACT
TUDORZA GENUAIR
CANADA
2409720
30 ACT /60 ACT INHALERS
Prescription
POWDER (METERED DOSE)
400MCG/ACT
DUAKLIR GENUAIR
CANADA
2439530
60 DOSES
Prescription
TABLET;ORAL
10MG **Federal Registe...
ELAVIL
USA
12703
1982-01-01
DISCN
TABLET;ORAL
25MG **Federal Registe...
ELAVIL
USA
12703
1982-01-01
DISCN
TABLET;ORAL
50MG **Federal Registe...
ELAVIL
USA
12703
1982-01-01
DISCN
TABLET;ORAL
75MG **Federal Registe...
ELAVIL
USA
12703
1982-01-01
DISCN
TABLET;ORAL
100MG **Federal Regist...
ELAVIL
USA
12703
1982-01-01
DISCN
TABLET;ORAL
150MG **Federal Regist...
ELAVIL
USA
12703
1982-01-01
DISCN
INJECTABLE;INJECTION
10MG/ML
ELAVIL
USA
12704
1982-01-01
DISCN
TABLET; ORAL
1MG
ARIMIDEX
USA
22214
TABLET
1MG
ARIMIDEX TAB 1MG
CANADA
2224135
30
Prescription
TAB
1mg
Everdex 1mg
SOUTH AFRICA
30X1mg
Generic
TAB
1mg
Arimidex 1mg
SOUTH AFRICA
30X1mg
Originator
tablet
1 mg
Arimidex
AUSTRALIA
30
INJECTABLE;INJECTION
0.5MG/ML **Federal Reg...
TENORMIN
USA
19058
1989-09-13
DISCN
TABLET
50MG
TENORETIC 50/25MG TAB
CANADA
2049961
28
Prescription
TABLET
100MG
TENORETIC 100/25MG TAB
CANADA
2049988
28
Prescription
TABLET
50MG
TENORMIN 50MG
CANADA
2039532
28
Prescription
TABLET
100MG
TENORMIN 100MG
CANADA
2039540
28
Prescription
TAB
100mg
Tenoretic
SOUTH AFRICA
30X1mg
Originator
TAB
100mg
Tenormin 100
SOUTH AFRICA
30X1mg
Originator
TAB
50mg
Tenormin 50
SOUTH AFRICA
30X1mg
Originator
TAB
50mg
Tenoret 50
SOUTH AFRICA
30X1mg
Originator
TAB
25mg
Tenormin 25
SOUTH AFRICA
30X1mg
Originator
tablet
50 mg
Tenormin
AUSTRALIA
30
INJECTABLE;INJECTION
30MG/ML
FASENRA
USA
761070
SOLUTION
30MG/ML
FASENRA
CANADA
2473232
1ML
Prescription
Fasenra
AUSTRALIA
1
Fasenra
AUSTRALIA
1
Fasenra
AUSTRALIA
1
Fasenra
AUSTRALIA
1
Fasenra
AUSTRALIA
1
Fasenra
AUSTRALIA
1
TABLET; ORAL
50MG
CASODEX
USA
22310
TABLET
50MG
CASODEX
CANADA
2184478
30
Prescription
TAB
50mg
Casodex 50
SOUTH AFRICA
30X1mg
Originator
TAB
150mg
Casodex
SOUTH AFRICA
30X1mg
Originator
tablet
50 mg
Cosudex
AUSTRALIA
28
INJECTABLE;INJECTION
50MG/ML
BRETYLIUM TOSYLATE
USA
71151
1987-08-10
DISCN
INJECTABLE;INJECTION
50MG/ML
BRETYLIUM TOSYLATE
USA
71152
1987-08-10
DISCN
INJECTABLE;INJECTION
50MG/ML
BRETYLIUM TOSYLATE
USA
71153
1987-08-10
DISCN
AEROSOL, METERED;NASAL
0.032MG/INH
RHINOCORT
USA
20233
1994-02-14
DISCN
POWDER, METERED;INHALA...
0.16MG/INH
PULMICORT
USA
20441
1997-06-24
DISCN
POWDER, METERED;INHALA...
0.32MG/INH
PULMICORT
USA
20441
1997-06-24
DISCN
SPRAY, METERED;NASAL
0.032MG/INH
RHINOCORT
USA
20746
SPRAY, METERED;NASAL
0.064MG/INH
RHINOCORT
USA
20746
SPRAY, METERED;NASAL
0.032MG/SPRAY
RHINOCORT ALLERGY
USA
20746
2015-03-23
OTC
SUSPENSION;INHALATION
0.25MG/2ML
PULMICORT RESPULES
USA
20929
2000-08-08
RX
SUSPENSION;INHALATION
0.5MG/2ML
PULMICORT RESPULES
USA
20929
2000-08-08
RX
SUSPENSION;INHALATION
1MG/2ML
PULMICORT RESPULES
USA
20929
2000-08-08
RX
POWDER, METERED;INHALA...
0.08MG/INH
PULMICORT FLEXHALER
USA
21949
2006-07-12
RX
POWDER, METERED;INHALA...
0.16MG/INH
PULMICORT FLEXHALER
USA
21949
2006-07-12
RX
SUSPENSION
0.125MG/ML
PULMICORT NEBUAMP 0.12...
CANADA
2229099
2ML
Prescription
SUSPENSION
0.25MG/ML
PULMICORT NEBUAMP 0.25...
CANADA
1978918
2ML
Prescription
POWDER (METERED DOSE)
400MCG/ACT
PULMICORT TURBUHALER
CANADA
851760
200 DOSES
Prescription
POWDER
100MCG/ACT
RHINOCORT TURBUHALER 1...
CANADA
2035324
200 DOSES
Prescription
SUSPENSION
0.5MG/ML
PULMICORT NEBUAMP 0.5 ...
CANADA
1978926
2ML
Prescription
POWDER (METERED DOSE)
200MCG/ACT
PULMICORT TURBUHALER
CANADA
851752
200 DOSES
Prescription
POWDER (METERED DOSE)
100MCG/ACT
PULMICORT TURBUHALER
CANADA
852074
200 DOSES
Prescription
POWDER
100MCG/ACT
SYMBICORT 100 TURBUHAL...
CANADA
2245385
60/120 DOSES
Prescription
POWDER
200MCG/ACT
SYMBICORT 200 TURBUHAL...
CANADA
2245386
60/120 DOSES
Prescription
AQS
64mcg
Rhinocort Aqua 120 Dos...
SOUTH AFRICA
120X1mcg
Originator