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Approved Drug Products of Astrazeneca Plc listed in the FDA Orange Book. Original Data : FDA Website

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01 ACALABRUTINIB (1)

02 ACALABRUTINIB MALEATE (1)

03 ALBUTEROL SULFATE; BUDESONIDE (1)

04 AMITRIPTYLINE HYDROCHLORIDE (7)

05 ANASTROZOLE (1)

06 ANIFROLUMAB-FNIA (1)

07 ASFOTASE ALFA (4)

08 ATENOLOL (1)

09 BENRALIZUMAB (1)

10 BETRIXABAN (2)

11 BICALUTAMIDE (1)

12 BRETYLIUM TOSYLATE (3)

13 BUDESONIDE (8)

14 BUDESONIDE; FORMOTEROL FUMARATE (1)

15 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE (2)

16 BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE (1)

17 CAPIVASERTIB (2)

18 DAPAGLIFLOZIN (2)

19 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE (5)

20 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE (4)

21 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE (2)

22 DEZOCINE (3)

23 DROPERIDOL (1)

24 DROPERIDOL; FENTANYL CITRATE (3)

25 DURVALUMAB (1)

26 DYCLONINE HYDROCHLORIDE (2)

27 ECULIZUMAB (1)

28 ENALAPRIL MALEATE; FELODIPINE (2)

29 EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE (2)

30 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE (1)

31 EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE (1)

32 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE (3)

33 EPLONTERSEN SODIUM (1)

34 ESOMEPRAZOLE MAGNESIUM (9)

35 ESOMEPRAZOLE SODIUM (2)

36 ETIDOCAINE HYDROCHLORIDE (2)

37 EXENATIDE SYNTHETIC (7)

38 FELODIPINE (3)

39 FORMOTEROL FUMARATE; GLYCOPYRROLATE (1)

40 FULVESTRANT (2)

41 FUROSEMIDE (1)

42 GEFITINIB (2)

43 ISOETHARINE HYDROCHLORIDE (10)

44 ISOSORBIDE DINITRATE (9)

45 LIDOCAINE (4)

46 LIDOCAINE HYDROCHLORIDE (4)

47 LIDOCAINE; PRILOCAINE (1)

48 METAPROTERENOL SULFATE (2)

49 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE (3)

50 NALOXONE HYDROCHLORIDE (1)

51 NIRSEVIMAB-ALIP (2)

52 OLAPARIB (3)

53 OMEGA-3-CARBOXYLIC ACIDS (1)

54 OMEPRAZOLE (3)

55 OMEPRAZOLE MAGNESIUM (1)

56 OSIMERTINIB MESYLATE (2)

57 PRAMLINTIDE ACETATE (3)

58 PRILOCAINE HYDROCHLORIDE (4)

59 QUETIAPINE FUMARATE (16)

60 RAVULIZUMAB-CWVZ (1)

61 RITODRINE HYDROCHLORIDE (3)

62 ROFLUMILAST (2)

63 ROSUVASTATIN CALCIUM (4)

64 SAXAGLIPTIN HYDROCHLORIDE (2)

65 SEBELIPASE ALFA (1)

66 SELUMETINIB SULFATE (2)

67 SODIUM ZIRCONIUM CYCLOSILICATE (2)

68 TAMOXIFEN CITRATE (2)

69 TEZEPELUMAB-EKKO (1)

70 TICAGRELOR (2)

71 TOCAINIDE HYDROCHLORIDE (2)

72 TREMELIMUMAB-ACTL (4)

73 TRIMETREXATE GLUCURONATE (2)

74 VITAMIN A (2)

75 ZOLMITRIPTAN (4)

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01 AEROSOL, METERED;INHALATION (6)

02 AEROSOL, METERED;NASAL (1)

03 AEROSOL;ORAL (1)

04 CAPSULE, DELAYED REL PELLETS;ORAL (5)

05 CAPSULE, DELAYED RELEASE;ORAL (1)

06 CAPSULE;ORAL (9)

07 DISC;TOPICAL (1)

08 FOR SUSPENSION, DELAYED RELEASE;ORAL (5)

09 FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS (2)

10 FOR SUSPENSION;ORAL (2)

11 INJECTABLE; IV (INFUSION) (1)

12 INJECTABLE; SUBCUTANEOUS (2)

13 INJECTABLE;INJECTION (41)

14 INJECTABLE;INTRAVENOUS (6)

15 INJECTABLE;SPINAL (1)

16 INJECTABLE;SUBCUTANEOUS (5)

17 OINTMENT;TOPICAL (1)

18 POWDER, METERED;INHALATION (4)

19 SOLUTION;INHALATION (12)

20 SOLUTION;INJECTION (4)

21 SOLUTION;INTRAMUSCULAR (2)

22 SOLUTION;SUBCUTANEOUS (2)

23 SOLUTION;TOPICAL (3)

24 SUPPOSITORY;RECTAL (1)

25 SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS (1)

26 SUSPENSION;INHALATION (3)

27 TABLET, CHEWABLE;ORAL (2)

28 TABLET, DELAYED RELEASE;ORAL (2)

29 TABLET, EXTENDED RELEASE; ORAL (4)

30 TABLET, EXTENDED RELEASE;ORAL (22)

31 TABLET, ORALLY DISINTEGRATING;ORAL (2)

32 TABLET; ORAL (2)

33 TABLET;ORAL (48)

34 TABLET;SUBLINGUAL (2)

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01 0.0048MG/INH;0.0090MG/INH (1)

02 0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

03 0.005MG/ML;1% (1)

04 0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

05 0.005MG/ML;1.5% (1)

06 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

07 0.005MG/ML;2% (1)

08 0.005MG/ML;4% (1)

09 0.02MG/ML (1)

10 0.032MG/INH (1)

11 0.062% (2)

12 0.08MG/INH (1)

13 0.08MG/INH;0.0045MG/INH (1)

14 0.125% (2)

15 0.167% (2)

16 0.16MG/INH (2)

17 0.16MG/INH;0.0045MG/INH (1)

18 0.16MG/INH;0.0048MG/INH (1)

19 0.16MG/INH;0.0048MG/INH;0.009MG/INH (1)

20 0.2% (2)

21 0.25% (2)

22 0.25MG/2ML (1)

23 0.32MG/INH (1)

24 0.4% (1)

25 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (2)

26 0.5MG/2ML (1)

27 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

28 0.6% (1)

29 1% (1)

30 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (3)

31 1.5% (1)

32 10% (1)

33 100MG (4)

34 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

35 10GM/PACKET (1)

36 10MG (4)

37 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (3)

38 10MG/ML (4)

39 10MG;1GM (1)

40 10MG;1GM;EQ 5MG BASE (1)

41 10MG;500MG (1)

42 10MG;EQ 5MG BASE (1)

43 125MG/2.5ML (50MG/ML) (1)

44 150MG (1)

45 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

46 15MG/ML (2)

47 160MG (1)

48 18MG/0.45ML (1)

49 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS (1)

50 1GM;EQ 2.5MG BASE (1)

51 1GM;EQ 5MG BASE (1)

52 1MG (1)

53 1MG/2ML (1)

54 2% (1)

55 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

56 2.5%;2.5% (1)

57 2.5MG (3)

58 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

59 2.5MG/ML (1)

60 2.5MG/ML;EQ 0.05MG BASE/ML (3)

61 2.5MG;1GM (1)

62 2.5MG;1GM;EQ 2.5MG BASE (1)

63 200MG (2)

64 20MG (1)

65 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

66 20MG/10ML (1)

67 210MG/1.91ML(110MG/ML) (1)

68 25,000USP UNITS (1)

69 250MCG (1)

70 250MG (2)

71 250MG/5ML (50MG/ML) (1)

72 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

73 25MG/1.25ML(20MG/ML) (2)

74 28MG/0.7ML (1)

75 2MG (1)

76 2MG/0.85ML (2MG/0.85ML) (1)

77 2MG/VIAL (1)

78 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

79 300MCG/1.2ML (250MCG/ML) (1)

80 300MG (2)

81 300MG/15ML(20MG/ML) (2)

82 300MG/2ML(150MG/ML) (1)

83 300MG/30ML(10MG/ML) (1)

84 300UGM/1.2ML (250UGM/ML) (1)

85 30MG (1)

86 30MG/ML (1)

87 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

88 400MG (2)

89 40MG (2)

90 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

91 40MG/ML (1)

92 5% (2)

93 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

94 50,000USP UNITS (1)

95 500MCG (1)

96 500MG;EQ 5MG BASE (1)

97 50MG (4)

98 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

99 50MG/ML (4)

100 5GM/PACKET (1)

101 5MG (6)

102 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

103 5MG/ML (1)

104 5MG;1GM (1)

105 5MG;1GM;EQ 2.5MG BASE (1)

106 5MG;1GM;EQ 5MG BASE (1)

107 5MG;2.5MG (1)

108 5MG;500MG (1)

109 5MG;5MG (1)

110 5MG;EQ 5MG BASE (1)

111 600MCG/2.4ML (250MCG/ML) (1)

112 600MG (1)

113 600UGM/2.4ML (250UGM/ML) (1)

114 60MG (1)

115 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

116 80MG (1)

117 80MG/0.8ML (1)

118 90MG (1)

119 EQ 0.09MG BASE/INH;0.08MG/INH (1)

120 EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) (1)

121 EQ 100MG BASE (2)

122 EQ 10MG BASE (2)

123 EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

124 EQ 10MG BASE/PACKET (1)

125 EQ 150MG BASE (1)

126 EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

127 EQ 2.5MG BASE (1)

128 EQ 2.5MG BASE/PACKET (1)

129 EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) (1)

130 EQ 200MG BASE (2)

131 EQ 200MG BASE/VIAL (1)

132 EQ 20MG BASE (5)

133 EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

134 EQ 20MG BASE/PACKET (1)

135 EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

136 EQ 25MG BASE (2)

137 EQ 25MG BASE/VIAL (1)

138 EQ 300MG BASE (2)

139 EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) (1)

140 EQ 400MG BASE (2)

141 EQ 40MG BASE (3)

142 EQ 40MG BASE/PACKET (1)

143 EQ 40MG BASE/VIAL (1)

144 EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) (1)

145 EQ 50MG BASE (2)

146 EQ 5MG BASE (2)

147 EQ 5MG BASE/PACKET (1)

148 EQ 80MG BASE (1)

filter

01 DISCN (111)

02 OTC (3)

03 RX (67)

04 Blank (25)

URL Supplier Web Content
CAPSULE; ORAL
100MG
2017-10-31
210259
CALQUENCE
RX
Yes
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TABLET; ORAL
EQ 100MG BASE
2022-08-03
216387
CALQUENCE
RX
Yes
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AEROSOL, METERED; ...
EQ 0.09MG BASE/INH...
2023-01-10
214070
AIRSUPRA
RX
Yes
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TABLET; ORAL
10MG **Federal Reg...
1982-01-01
12703
ELAVIL
DISCN
Yes
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TABLET; ORAL
25MG **Federal Reg...
1982-01-01
12703
ELAVIL
DISCN
Yes
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TABLET; ORAL
50MG **Federal Reg...
1982-01-01
12703
ELAVIL
DISCN
Yes
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TABLET; ORAL
75MG **Federal Reg...
1982-01-01
12703
ELAVIL
DISCN
Yes
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TABLET; ORAL
100MG **Federal Re...
1982-01-01
12703
ELAVIL
DISCN
Yes
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TABLET; ORAL
150MG **Federal Re...
1982-01-01
12703
ELAVIL
DISCN
Yes
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INJECTABLE; INJECT...
10MG/ML
1982-01-01
12704
ELAVIL
DISCN
No
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