Application 207709
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;7.5MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 300MG;10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13107-211 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-211 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-211 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-211 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-211 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-212 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-212 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-212 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-212 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-212 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-213 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-213 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-213 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-213 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
| 13107-213 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Aurolife Pharma, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76220 | ORIG | 2023-11-03 |