Prostaglandin E1 Analog Drug Class List
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Drugs in Drug Class: Prostaglandin E1 Analog
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-003 | Sep 21, 1990 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 203995-001 | Nov 25, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 203995-002 | Nov 25, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 204355-001 | Jul 15, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
