Details for New Drug Application (NDA): 021951
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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 |
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 | 021951-001 | May 25, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-004 | May 25, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-005 | Aug 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-006 | Aug 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-004 | May 25, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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