Details for New Drug Application (NDA): 211913
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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
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 8MG | ||||
| Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 29, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 16MG | ||||
| Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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