Details for New Drug Application (NDA): 205831
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NDA 205831 describes APTENSIO XR, which is a drug marketed by Rhodes Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the APTENSIO XR profile page.
The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 205831
| Tradename: | APTENSIO XR |
| Applicant: | Rhodes Pharms |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205831
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 205831
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals | 42858-075 | 42858-075-45 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45) |
| APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals | 42858-076 | 42858-076-45 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 17, 2015 | TE: | AB3 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Apr 17, 2015 | TE: | AB3 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 17, 2015 | TE: | AB3 | RLD: | Yes | ||||
Expired US Patents for NDA 205831
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-005 | Apr 17, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-001 | Apr 17, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-007 | Apr 17, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-006 | Apr 17, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-004 | Apr 17, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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