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Approved Drug Products of Apotex Inc listed in the FDA Orange Book. Original Data : FDA Website

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01 1ABACAVIR SULFATE

02 1ABIRATERONE ACETATE

03 4ACYCLOVIR

04 1ADEFOVIR DIPIVOXIL

05 4ALBUTEROL SULFATE

06 1ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

07 4ALENDRONATE SODIUM

08 1ALFUZOSIN HYDROCHLORIDE

09 8ALPRAZOLAM

10 2AMBRISENTAN

11 8AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

12 6AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

13 3AMOXICILLIN; CLAVULANATE POTASSIUM

14 1ANASTROZOLE

15 2APIXABAN

16 7ARIPIPRAZOLE

17 7ATOMOXETINE HYDROCHLORIDE

18 4ATORVASTATIN CALCIUM

19 1ATOVAQUONE

20 1ATROPINE SULFATE

21 2AXITINIB

22 5AZELASTINE HYDROCHLORIDE

23 1AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

24 3AZITHROMYCIN

25 1BALSALAZIDE DISODIUM

26 4BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

27 3BENDAMUSTINE HYDROCHLORIDE

28 1BEPOTASTINE BESILATE

29 1BETAXOLOL HYDROCHLORIDE

30 1BICALUTAMIDE

31 3BIMATOPROST

32 1BIVALIRUDIN

33 1BORTEZOMIB

34 2BRIMONIDINE TARTRATE

35 1BRIMONIDINE TARTRATE; TIMOLOL MALEATE

36 5BRIVARACETAM

37 3BROMFENAC SODIUM

38 2BUDESONIDE

39 2BUPROPION HYDROCHLORIDE

40 1BUSULFAN

41 1BUTORPHANOL TARTRATE

42 1CABAZITAXEL

43 1CABERGOLINE

44 1CALCITONIN SALMON

45 4CANDESARTAN CILEXETIL

46 3CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

47 7CARBAMAZEPINE

48 5CARBIDOPA; LEVODOPA

49 2CARFILZOMIB

50 1CARTEOLOL HYDROCHLORIDE

51 4CEFPROZIL

52 2CEFTAROLINE FOSAMIL

53 2CEFUROXIME AXETIL

54 3CELECOXIB

55 3CETIRIZINE HYDROCHLORIDE

56 1CEVIMELINE HYDROCHLORIDE

57 2CILOSTAZOL

58 2CIMETIDINE

59 3CITALOPRAM HYDROBROMIDE

60 1CLEMASTINE FUMARATE

61 2CLOBAZAM

62 1CLOBETASOL PROPIONATE

63 2CLOPIDOGREL BISULFATE

64 1CROMOLYN SODIUM

65 2CYCLOBENZAPRINE HYDROCHLORIDE

66 6CYCLOSPORINE

67 3DABIGATRAN ETEXILATE MESYLATE

68 2DAPAGLIFLOZIN

69 6DASATINIB

70 3DESMOPRESSIN ACETATE

71 7DEXAMETHASONE

72 2DICLOFENAC SODIUM

73 12DILTIAZEM HYDROCHLORIDE

74 3DIVALPROEX SODIUM

75 2DOCETAXEL

76 2DONEPEZIL HYDROCHLORIDE

77 4DOXAZOSIN MESYLATE

78 1DOXYCYCLINE

79 2DOXYCYCLINE HYCLATE

80 1DROSPIRENONE; ETHINYL ESTRADIOL

81 3DULOXETINE HYDROCHLORIDE

82 1DUTASTERIDE

83 2ELETRIPTAN HYDROBROMIDE

84 1ELIGLUSTAT TARTRATE

85 2EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

86 1EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

87 1ENZALUTAMIDE

88 1EPINASTINE HYDROCHLORIDE

89 3ERLOTINIB HYDROCHLORIDE

90 4ESLICARBAZEPINE ACETATE

91 1ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

92 4ETODOLAC

93 1EZETIMIBE

94 3FAMCICLOVIR

95 4FAMOTIDINE

96 2FENOFIBRATE

97 1FINGOLIMOD HYDROCHLORIDE

98 1FLUNISOLIDE

99 4FLUPHENAZINE HYDROCHLORIDE

100 2FLUTICASONE PROPIONATE

101 3FLUVOXAMINE MALEATE

102 1FOSAPREPITANT DIMEGLUMINE

103 3FOSINOPRIL SODIUM

104 1FOSPHENYTOIN SODIUM

105 1FULVESTRANT

106 3GABAPENTIN

107 3GALANTAMINE HYDROBROMIDE

108 1GATIFLOXACIN

109 1GEFITINIB

110 3GEMCITABINE HYDROCHLORIDE

111 1GEMFIBROZIL

112 2GLIPIZIDE

113 1GLYCOPYRROLATE

114 1GRANISETRON HYDROCHLORIDE

115 4GUANFACINE HYDROCHLORIDE

116 3HYDROCHLOROTHIAZIDE

117 3HYDROCHLOROTHIAZIDE; IRBESARTAN

118 3HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

119 3HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

120 2HYDROCHLOROTHIAZIDE; TRIAMTERENE

121 5HYDROCHLOROTHIAZIDE; VALSARTAN

122 2IBANDRONATE SODIUM

123 1ICOSAPENT ETHYL

124 2IMATINIB MESYLATE

125 1IMIQUIMOD

126 3IPRATROPIUM BROMIDE

127 3IRBESARTAN

128 1ITRACONAZOLE

129 4KETOROLAC TROMETHAMINE

130 1KETOTIFEN FUMARATE

131 6LACOSAMIDE

132 3LAMIVUDINE

133 1LATANOPROST

134 2LEFLUNOMIDE

135 6LENALIDOMIDE

136 1LETROZOLE

137 4LEVETIRACETAM

138 2LEVOBUNOLOL HYDROCHLORIDE

139 4LEVOCETIRIZINE DIHYDROCHLORIDE

140 3LEVOFLOXACIN

141 7LISDEXAMFETAMINE DIMESYLATE

142 1LITHIUM CARBONATE

143 1LORATADINE

144 6LOSARTAN POTASSIUM

145 1MACITENTAN

146 1MELPHALAN

147 2MELPHALAN HYDROCHLORIDE

148 5MEMANTINE HYDROCHLORIDE

149 3METAPROTERENOL SULFATE

150 10METFORMIN HYDROCHLORIDE

151 2MICAFUNGIN SODIUM

152 3MIDODRINE HYDROCHLORIDE

153 3MINOXIDIL

154 3MIRTAZAPINE

155 2MODAFINIL

156 2MOEXIPRIL HYDROCHLORIDE

157 2MOMETASONE FUROATE

158 3MONTELUKAST SODIUM

159 1MOXIFLOXACIN HYDROCHLORIDE

160 2MYCOPHENOLATE MOFETIL

161 2MYCOPHENOLIC SODIUM

162 2NARATRIPTAN HYDROCHLORIDE

163 2NEBIVOLOL HYDROCHLORIDE

164 2NEVIRAPINE

165 3NILOTINIB HYDROCHLORIDE

166 2NIZATIDINE

167 2OBETICHOLIC ACID

168 2OFLOXACIN

169 10OLANZAPINE

170 4OLOPATADINE HYDROCHLORIDE

171 1OMEGA-3-ACID ETHYL ESTERS

172 4OMEPRAZOLE

173 4ONDANSETRON HYDROCHLORIDE

174 3OXCARBAZEPINE

175 18PAROXETINE HYDROCHLORIDE

176 1PAZOPANIB HYDROCHLORIDE

177 4PEMETREXED DISODIUM

178 1PENICILLAMINE

179 1PENTOXIFYLLINE

180 3PERINDOPRIL ERBUMINE

181 3PIRFENIDONE

182 4POMALIDOMIDE

183 2PONATINIB HYDROCHLORIDE

184 2POTASSIUM CHLORIDE

185 4PRAVASTATIN SODIUM

186 19PREGABALIN

187 4QUINAPRIL HYDROCHLORIDE

188 4RAMIPRIL

189 5RANITIDINE HYDROCHLORIDE

190 2RASAGILINE MESYLATE

191 1REGADENOSON

192 1RILUZOLE

193 3RISEDRONATE SODIUM

194 6RISPERIDONE

195 4RIVASTIGMINE TARTRATE

196 4RIZATRIPTAN BENZOATE

197 4ROSUVASTATIN CALCIUM

198 2SELEGILINE HYDROCHLORIDE

199 4SILDENAFIL CITRATE

200 1SIROLIMUS

201 3SITAGLIPTIN PHOSPHATE

202 2SITAGLIPTIN; METFORMIN HYDROCHLORIDE

203 7SOTALOL HYDROCHLORIDE

204 2TAMOXIFEN CITRATE

205 1TASIMELTEON

206 6TEMOZOLOMIDE

207 1TENOFOVIR ALAFENAMIDE FUMARATE

208 2TERIFLUNOMIDE

209 1TERIPARATIDE

210 1TESTOSTERONE

211 2TETRABENAZINE

212 1TICLOPIDINE HYDROCHLORIDE

213 1TIGECYCLINE

214 3TIMOLOL MALEATE

215 5TIZANIDINE HYDROCHLORIDE

216 1TOBRAMYCIN

217 2TOLTERODINE TARTRATE

218 2TOLVAPTAN

219 1TRAMADOL HYDROCHLORIDE

220 2TRANEXAMIC ACID

221 1TRAVOPROST

222 4TRAZODONE HYDROCHLORIDE

223 1TRIAMCINOLONE ACETONIDE

224 1TROSPIUM CHLORIDE

225 2VALACYCLOVIR HYDROCHLORIDE

226 2VARENICLINE TARTRATE

227 3VERAPAMIL HYDROCHLORIDE

228 3VILAZODONE HYDROCHLORIDE

229 1ZINC SULFATE

230 4ZIPRASIDONE HYDROCHLORIDE

231 2ZOLEDRONIC ACID

232 4ZOLMITRIPTAN

233 4ZOLPIDEM TARTRATE

234 3ZONISAMIDE

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PharmaCompass

01

Brand Name : ABACAVIR SULFATE

BioProcess International
Not Confirmed
arrow

Brand Name : ABACAVIR SULFATE

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : TABLET; ORAL

Proprietary Name : ABACAVIR SULFATE

Dosage Strength : EQ 300MG BASE

Approval Date : 2012-12-17

Application Number : 201570

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Brand Name : ABIRATERONE ACETATE

BioProcess International
Not Confirmed
arrow

Brand Name : ABIRATERONE ACETATE

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : TABLET; ORAL

Proprietary Name : ABIRATERONE ACETATE

Dosage Strength : 250MG

Approval Date : 2018-10-31

Application Number : 208453

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

03

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : CAPSULE; ORAL

Proprietary Name : ACYCLOVIR

Dosage Strength : 200MG

Approval Date : 2005-09-28

Application Number : 75677

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

04

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : TABLET; ORAL

Proprietary Name : ACYCLOVIR

Dosage Strength : 400MG

Approval Date : 2005-09-29

Application Number : 77309

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

05

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : TABLET; ORAL

Proprietary Name : ACYCLOVIR

Dosage Strength : 800MG

Approval Date : 2005-09-29

Application Number : 77309

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

06

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Brand Name : ACYCLOVIR

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : OINTMENT; TOPICAL

Proprietary Name : ACYCLOVIR

Dosage Strength : 5%

Approval Date : 2019-09-06

Application Number : 210774

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

07

Brand Name : ADEFOVIR DIPIVOXIL

BioProcess International
Not Confirmed
arrow

Brand Name : ADEFOVIR DIPIVOXIL

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : TABLET; ORAL

Proprietary Name : ADEFOVIR DIPIVOXIL

Dosage Strength : 10MG

Approval Date : 2018-07-06

Application Number : 205459

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : SOLUTION; INHALATION

Proprietary Name : ALBUTEROL SULFATE

Dosage Strength : EQ 0.083% BASE

Approval Date : 2007-02-02

Application Number : 75717

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : SOLUTION; INHALATION

Proprietary Name : ALBUTEROL SULFATE

Dosage Strength : EQ 0.021% BASE

Approval Date : 2010-04-05

Application Number : 78623

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Brand Name : ALBUTEROL SULFATE

BioProcess International
Not Confirmed
arrow

Apotex Inc

Dosage Form : SOLUTION; INHALATION

Proprietary Name : ALBUTEROL SULFATE

Dosage Strength : EQ 0.042% BASE

Approval Date : 2010-04-05

Application Number : 78623

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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