Details for New Drug Application (NDA): 211913
✉ Email this page to a colleague
NDA 211913 describes ABSORICA LD, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ABSORICA LD profile page.
The generic ingredient in ABSORICA LD is isotretinoin. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in ABSORICA LD is isotretinoin. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 211913
| Tradename: | ABSORICA LD |
| Applicant: | Sun Pharm |
| Ingredient: | isotretinoin |
| Patents: | 2 |
Suppliers and Packaging for NDA: 211913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-002 | 10631-002-31 | 3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK |
| ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-003 | 10631-003-31 | 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 16MG | ||||
| Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 9,700,535 | Patent Expiration: | Aug 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
