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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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01 13Granules India Limited
02 6ANI Pharmaceuticals Inc
03 7Accord healthcare
04 17Actavis Inc
05 13Ajanta Pharma Limited
06 7Alkem Laboratories
07 7Alvogen
08 13Aurolife Pharma LLC
09 13Barr Laboratories
10 6CorePharma, LLC
11 6ENDO OPERATIONS
12 13Elite Laboratories
13 7Epic Pharma. LLC.
14 6Impax Laboratories
15 13Lannett Company, Inc.
16 17Mallinckrodt Pharmaceuticals
17 7NORVIUM BIOSCIENCE
18 5Neolpharma
19 6Nesher Pharmaceuticals USA LLC
20 7Nuvo Pharmaceuticals
21 13RHODES PHARMACEUTICALS LP
22 4Sandoz B2B
23 17Sun Pharmaceutical Industries Limited
24 10Takeda Pharmaceutical
25 21Teva Pharmaceutical Industries
26 6USpharma
27 7Zydus Pharmaceuticals
01 118CAPSULE, EXTENDED RELEASE;ORAL
02 149TABLET;ORAL
01 70DISCN
02 191RX
03 6Blank
01 1ADDERALL 10
02 1ADDERALL 12.5
03 1ADDERALL 15
04 1ADDERALL 20
05 1ADDERALL 30
06 1ADDERALL 5
07 1ADDERALL 7.5
08 1ADDERALL XR 10
09 1ADDERALL XR 15
10 1ADDERALL XR 20
11 1ADDERALL XR 25
12 1ADDERALL XR 30
13 1ADDERALL XR 5
14 238DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
15 6DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
16 6DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAM
17 4MYDAYIS
01 267USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.875MG;1.875MG;1.875MG;1.875MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.125MG;3.125MG;3.125MG;3.125MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG;5MG;5MG;5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG;5MG;5MG;5MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 6.25MG;6.25MG;6.25MG;6.25MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Packaging :
Approval Date : 2023-10-06
Application Number : 217787
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 10
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1996-02-13
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 20
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1996-02-13
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 5
Dosage Form : TABLET;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1997-05-12
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 30
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1997-05-12
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 7.5
Dosage Form : TABLET;ORAL
Dosage Strength : 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2000-08-31
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : ADDERALL 12.5
Dosage Form : TABLET;ORAL
Dosage Strength : 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2000-08-31
Application Number : 11522
Regulatory Info : DISCN
Registration Country : USA
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