Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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01 8Granules India Limited
02 3ABHAI INC
03 8Adare Pharma Solutions
04 8Ajanta Pharma Limited
05 3Alkem Laboratories
06 8Aurolife Pharma LLC
07 2Bionpharma
08 3COMMAVE THERAP
09 8ENDO OPERATIONS
10 7Impax Laboratories
11 6Intellipharmaceutics Corporation
12 3Lannett Company, Inc.
13 2Neolpharma
14 3Novel Laboratories, Inc.
15 3RHODES PHARMACEUTICALS LP
16 19Sandoz B2B
17 11Sun Pharmaceutical Industries Limited
18 12Teva Pharmaceutical Industries
19 3Tris Pharma Inc
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01 78CAPSULE, EXTENDED RELEASE;ORAL
02 3CAPSULE;ORAL
03 2Ret Caps
04 6Ret Kaps
05 31TABLET;ORAL
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01 16DISCN
02 95RX
03 9Blank
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01 3AZSTARYS
02 98DEXMETHYLPHENIDATE HYDROCHLORIDE
03 3FOCALIN
04 8FOCALIN XR
05 8Focalin XR
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01 8Switzerland
02 112USA
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 35MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 40MG
Packaging :
Approval Date : 2020-09-09
Application Number : 213813
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG
Packaging :
Approval Date : 2001-11-13
Application Number : 21278
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2001-11-13
Application Number : 21278
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2001-11-13
Application Number : 21278
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2005-05-26
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2005-05-26
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2005-05-26
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2006-08-01
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2009-10-23
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 40MG
Packaging :
Approval Date : 2010-08-11
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 35MG
Packaging :
Approval Date : 2011-04-21
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : FOCALIN XR
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Packaging :
Approval Date : 2011-04-21
Application Number : 21802
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
DEXMETHYLPHENIDATE HYDROCHLORIDE
Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2007-01-29
Application Number : 77107
Regulatory Info : DISCN
Registration Country : USA
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