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Application 021171
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | Yes | Yes |
| 002 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | Yes | Yes |
| 003 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 75MG/ML | Yes | Yes |
| 004 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1176 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1178 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1179 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1180 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1181 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1201 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1203 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1253 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1253 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1253 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1253 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1253 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1254 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1254 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1254 | DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84651 | SUPPL | 2026-01-06 |
| 84567 | SUPPL | 2025-12-29 |
| 80822 | SUPPL | 2025-01-08 |
| 80821 | SUPPL | 2025-01-08 |
| 77000 | SUPPL | 2023-12-19 |
| 76903 | SUPPL | 2023-12-18 |
| 72475 | SUPPL | 2022-10-26 |
| 60434 | SUPPL | 2019-10-09 |
| 60282 | SUPPL | 2019-10-07 |
| 46359 | SUPPL | 2016-12-21 |
| 46358 | SUPPL | 2016-12-21 |
| 46277 | SUPPL | 2016-12-20 |
| 46276 | SUPPL | 2016-12-20 |