Details for New Drug Application (NDA): 021951
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NDA 021951 describes ABSORICA, which is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and five Paragraph IV challenges. Additional details are available on the ABSORICA profile page.
The generic ingredient in ABSORICA is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in ABSORICA is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 021951
| Tradename: | ABSORICA |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | isotretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021951
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | isotretinoin | CAPSULE;ORAL | 021951 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-115 | 10631-115-31 | 3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BLISTER PACK (10631-115-69) |
| ABSORICA | isotretinoin | CAPSULE;ORAL | 021951 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-116 | 10631-116-31 | 3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 25, 2012 | TE: | AB2 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | May 25, 2012 | TE: | AB2 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | May 25, 2012 | TE: | AB2 | RLD: | Yes | ||||
Expired US Patents for NDA 021951
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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