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Approved Drug Products of Alkem Laboratories listed in the FDA Orange Book. Original Data : FDA Website

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01 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE (1)

02 AMLODIPINE BESYLATE (3)

03 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL (4)

04 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (7)

05 AMPHETAMINE SULFATE (2)

06 APREMILAST (3)

07 ARIPIPRAZOLE (6)

08 ATORVASTATIN CALCIUM (4)

09 AZATHIOPRINE (4)

10 AZELASTINE HYDROCHLORIDE (1)

11 BENZONATATE (5)

12 BREXPIPRAZOLE (1)

13 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE (1)

14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE (2)

15 CAPECITABINE (2)

16 CEFDINIR (3)

17 CEFIXIME (3)

18 CEFPODOXIME PROXETIL (2)

19 CEFPROZIL (2)

20 CEFUROXIME AXETIL (2)

21 CEPHALEXIN (6)

22 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE (1)

23 CHLORTHALIDONE (2)

24 CHOLESTYRAMINE (4)

25 CINACALCET HYDROCHLORIDE (3)

26 CLOBAZAM (4)

27 CLOPIDOGREL BISULFATE (1)

28 COLCHICINE (1)

29 COLESEVELAM HYDROCHLORIDE (2)

30 DABIGATRAN ETEXILATE MESYLATE (2)

31 DALFAMPRIDINE (1)

32 DEFERASIROX (9)

33 DEXMETHYLPHENIDATE HYDROCHLORIDE (3)

34 DICLOFENAC POTASSIUM (1)

35 DIMETHYL FUMARATE (2)

36 DRONABINOL (3)

37 DRONEDARONE HYDROCHLORIDE (1)

38 DROXIDOPA (3)

39 DULOXETINE HYDROCHLORIDE (3)

40 EMPAGLIFLOZIN (2)

41 EMPAGLIFLOZIN;LINAGLIPTIN (2)

42 ENALAPRIL MALEATE (1)

43 ERYTHROMYCIN (2)

44 ESLICARBAZEPINE ACETATE (4)

45 ESOMEPRAZOLE MAGNESIUM (2)

46 EVEROLIMUS (4)

47 EZETIMIBE (1)

48 EZETIMIBE; SIMVASTATIN (4)

49 FAMOTIDINE (5)

50 FAMOTIDINE; IBUPROFEN (1)

51 FEBUXOSTAT (2)

52 FESOTERODINE FUMARATE (2)

53 FINASTERIDE (2)

54 FINGOLIMOD HYDROCHLORIDE (1)

55 FOSFOMYCIN TROMETHAMINE (1)

56 GABAPENTIN (5)

57 HYDRALAZINE HYDROCHLORIDE (4)

58 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL (3)

59 IBUPROFEN (3)

60 ISONIAZID (2)

61 ITRACONAZOLE (1)

62 LACOSAMIDE (5)

63 LAMIVUDINE (1)

64 LAMOTRIGINE (4)

65 LANSOPRAZOLE (2)

66 LEVETIRACETAM (4)

67 LIDOCAINE (1)

68 LINEZOLID (1)

69 LISDEXAMFETAMINE DIMESYLATE (7)

70 LURASIDONE HYDROCHLORIDE (5)

71 MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE (1)

72 MESALAMINE (1)

73 METFORMIN HYDROCHLORIDE (5)

74 METHADONE HYDROCHLORIDE (2)

75 METHYLPHENIDATE HYDROCHLORIDE (10)

76 METOPROLOL SUCCINATE (4)

77 MINOCYCLINE HYDROCHLORIDE (8)

78 MIRABEGRON (2)

79 MORPHINE SULFATE (2)

80 MYCOPHENOLATE MOFETIL (3)

81 MYCOPHENOLIC SODIUM (2)

82 NEBIVOLOL HYDROCHLORIDE (4)

83 NIFEDIPINE (3)

84 NIMODIPINE (3)

85 OLANZAPINE (6)

86 OLMESARTAN MEDOXOMIL (3)

87 OXCARBAZEPINE (1)

88 OXYCODONE HYDROCHLORIDE (2)

89 PREGABALIN (9)

90 QUETIAPINE FUMARATE (7)

91 RABEPRAZOLE SODIUM (1)

92 RANOLAZINE (2)

93 RASAGILINE MESYLATE (4)

94 RILUZOLE (1)

95 RIZATRIPTAN BENZOATE (2)

96 ROFLUMILAST (2)

97 ROSUVASTATIN CALCIUM (4)

98 RUFINAMIDE (1)

99 SILDENAFIL CITRATE (1)

100 SILVER SULFADIAZINE (1)

101 SIROLIMUS (3)

102 SITAGLIPTIN PHOSPHATE (2)

103 SOLIFENACIN SUCCINATE (2)

104 TACROLIMUS (3)

105 TAMSULOSIN HYDROCHLORIDE (1)

106 TAPENTADOL (3)

107 TEMAZEPAM (4)

108 TICAGRELOR (1)

109 TIZANIDINE HYDROCHLORIDE (5)

110 TOBRAMYCIN (1)

111 TOLVAPTAN (3)

112 TOPIRAMATE (6)

113 TRIAMCINOLONE ACETONIDE (3)

114 VALSARTAN (4)

115 VANCOMYCIN HYDROCHLORIDE (2)

116 VARENICLINE TARTRATE (2)

117 VENLAFAXINE HYDROCHLORIDE (4)

118 VIGABATRIN (1)

119 VORTIOXETINE (4)

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01 CAPSULE, DELAYED REL PELLETS;ORAL (7)

02 CAPSULE, DELAYED RELEASE;ORAL (2)

03 CAPSULE, EXTENDED RELEASE;ORAL (5)

04 CAPSULE;ORAL (55)

05 CREAM;TOPICAL (4)

06 FOR SOLUTION;ORAL (5)

07 FOR SUSPENSION;ORAL (10)

08 GRANULE;ORAL (3)

09 OINTMENT;TOPICAL (1)

10 POWDER;ORAL (4)

11 SOLUTION;INHALATION (1)

12 SOLUTION;ORAL (10)

13 SPRAY, METERED;NASAL (1)

14 SUSPENSION;ORAL (3)

15 SYRUP;ORAL (1)

16 TABLET, DELAYED RELEASE;ORAL (3)

17 TABLET, EXTENDED RELEASE;ORAL (33)

18 TABLET, FOR SUSPENSION;ORAL (3)

19 TABLET; ORAL (1)

20 TABLET;ORAL (191)

21 TABLET;SUBLINGUAL (2)

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01 0.025% (1)

02 0.1% (1)

03 0.137MG/SPRAY (1)

04 0.25MG (2)

05 0.4MG (1)

06 0.5% (1)

07 0.5MG (2)

08 0.6MG (1)

09 0.75MG (1)

10 1% (1)

11 1.25MG;1.25MG;1.25MG;1.25MG (1)

12 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT (1)

13 1.875MG;1.875MG;1.875MG;1.875MG (1)

14 100MG (12)

15 100MG/5ML (2)

16 10MG (16)

17 10MG/5MG (1)

18 10MG/5ML (1)

19 10MG/ML (1)

20 10MG;10MG (1)

21 10MG;20MG (1)

22 10MG;40MG (1)

23 10MG;80MG (1)

24 12.5MG;20MG (1)

25 12.5MG;40MG (1)

26 120MG (2)

27 125MG (1)

28 125MG/5ML (1)

29 150MG (7)

30 15MG (8)

31 160MG (1)

32 180MG (2)

33 18MG (1)

34 1GM (3)

35 1MG (3)

36 1MG/ML (1)

37 2.5MG (3)

38 2.5MG/ML (1)

39 2.5MG;2.5MG;2.5MG;2.5MG (1)

40 200MG (8)

41 200MG/5ML (1)

42 200MG/ML (1)

43 20MG (13)

44 20MG/ML (1)

45 22.5MG (1)

46 225MG (1)

47 240MG (1)

48 250MCG (1)

49 250MG (5)

50 250MG/5ML (1)

51 25MG (9)

52 25MG/5MG (1)

53 25MG;40MG (1)

54 26.6MG;800MG (1)

55 27MG (1)

56 2MG (2)

57 2MG/5ML;10MG/5ML;30MG/5ML (1)

58 3.125MG;3.125MG;3.125MG;3.125MG (1)

59 3.75GM/PACKET (1)

60 3.75MG;3.75MG;3.75MG;3.75MG (1)

61 300MG (5)

62 300MG/5ML (2)

63 30MG (9)

64 30MG/5ML (1)

65 320MG (1)

66 325MG;37.5MG (1)

67 360MG (2)

68 36MG (1)

69 375MG (1)

70 400MG (5)

71 40MG (7)

72 40MG/5ML (1)

73 40MG/ML (1)

74 4MG (1)

75 5% (1)

76 500MCG (1)

77 500MG (9)

78 500MG/PACKET (1)

79 50MG (11)

80 54MG (1)

81 5MG (12)

82 5MG/5ML (2)

83 5MG;2.5MG (1)

84 5MG;5MG;5MG;5MG (1)

85 600MG (4)

86 60MG (4)

87 60MG/10ML (1)

88 625MG (1)

89 7.5MG (2)

90 7.5MG;7.5MG;7.5MG;7.5MG (1)

91 70MG (1)

92 750MG (2)

93 75MG (3)

94 800MG (3)

95 80MG (3)

96 850MG (1)

97 8MG (1)

98 90MG (4)

99 EQ 0.5MG BASE (5)

100 EQ 100MG BASE (3)

101 EQ 100MG TARTRATE (1)

102 EQ 105MG BASE (1)

103 EQ 10MG BASE (5)

104 EQ 10MG BASE/ML (1)

105 EQ 10MG BASE;20MG (1)

106 EQ 10MG BASE;40MG (1)

107 EQ 115MG BASE (1)

108 EQ 125MG BASE/5ML (1)

109 EQ 135MG BASE (1)

110 EQ 150MG BASE (3)

111 EQ 180MG BASE (1)

112 EQ 1MG BASE (4)

113 EQ 2.5MG BASE (2)

114 EQ 200MG BASE (2)

115 EQ 200MG TARTRATE (1)

116 EQ 20MG BASE (5)

117 EQ 225MG BASE (1)

118 EQ 250MG BASE (2)

119 EQ 250MG BASE/5ML (1)

120 EQ 25MG BASE (1)

121 EQ 25MG BASE/ML (1)

122 EQ 25MG TARTRATE (1)

123 EQ 2MG BASE (2)

124 EQ 2MG BASE;EQ 0.5MG BASE (1)

125 EQ 300MG BASE (1)

126 EQ 30MG BASE (2)

127 EQ 333MG BASE (1)

128 EQ 360MG BASE (1)

129 EQ 37.5MG BASE (1)

130 EQ 3GM BASE/PACKET (1)

131 EQ 400MG BASE (1)

132 EQ 40MG BASE (3)

133 EQ 45MG BASE (1)

134 EQ 4GM RESIN/PACKET (2)

135 EQ 4GM RESIN/SCOOPFUL (2)

136 EQ 4MG BASE (2)

137 EQ 500MG BASE (2)

138 EQ 50MG BASE (2)

139 EQ 50MG BASE/ML (1)

140 EQ 50MG TARTRATE (1)

141 EQ 55MG BASE (1)

142 EQ 5MG BASE (5)

143 EQ 5MG BASE;20MG (1)

144 EQ 5MG BASE;40MG (1)

145 EQ 60MG BASE (2)

146 EQ 65MG BASE (1)

147 EQ 6MG BASE (1)

148 EQ 750MG BASE (1)

149 EQ 75MG BASE (3)

150 EQ 80MG BASE (2)

151 EQ 8MG BASE;EQ 2MG BASE (1)

152 EQ 90MG BASE (2)

filter

01 DISCN (7)

02 RX (314)

03 Blank (24)

URL Supplier Web Content
TABLET; ORAL
325MG;37.5MG
2012-03-30
202076
TRAMADOL HYDROCHLO...
RX
No
AB
ASK
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URL Supplier Web Content
TABLET; ORAL
EQ 2.5MG BASE
2009-05-04
78925
AMLODIPINE BESYLAT...
RX
No
AB
ASK
US
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your Marketing & Sales content
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TABLET; ORAL
EQ 5MG BASE
2009-05-04
78925
AMLODIPINE BESYLAT...
RX
No
AB
ASK
US
PHARMACOMPASS
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your Marketing & Sales content
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TABLET; ORAL
EQ 10MG BASE
2009-05-04
78925
AMLODIPINE BESYLAT...
RX
No
AB
ASK
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PHARMACOMPASS
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your Marketing & Sales content
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TABLET; ORAL
EQ 5MG BASE;20MG
2017-08-14
209042
AMLODIPINE AND OLM...
RX
No
AB
ASK
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your Marketing & Sales content
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TABLET; ORAL
EQ 5MG BASE;40MG
2017-08-14
209042
AMLODIPINE AND OLM...
RX
No
AB
ASK
US
PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
TABLET; ORAL
EQ 10MG BASE;20MG
2017-08-14
209042
AMLODIPINE AND OLM...
RX
No
AB
ASK
US
PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
TABLET; ORAL
EQ 10MG BASE;40MG
2017-08-14
209042
AMLODIPINE AND OLM...
RX
No
AB
ASK
US
PHARMACOMPASS
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TABLET; ORAL
1.25MG;1.25MG;1.25...
2023-10-06
217787
DEXTROAMP SACCHARA...
RX
No
AB
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TABLET; ORAL
1.875MG;1.875MG;1....
2023-10-06
217787
DEXTROAMP SACCHARA...
RX
No
AB
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US
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