Application 091071

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No
002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL			2015-05-27
A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL			2015-05-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091071-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091071-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-05-27	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	c857bcd9-6696-40d5-93c0-65097598cd4b	2022-04-08	Warnings	Name fallback brand name: Guaifenesin and Pseudoephedrine Hydrochloride
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	d139fd8d-66fd-4484-8e78-ed90c505d999	2022-02-08	Warnings	Name fallback brand name: Guaifenesin and Pseudoephedrine Hydrochloride
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN COMPANY	310d14be-e7ea-44b8-8b04-cffa39440d50	2018-10-27	Warnings	Name fallback brand name: Guaifenesin and Pseudoephedrine Hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-2002	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	L. Perrigo Company	ANDA	Current
0113-2002	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	L. Perrigo Company	ANDA	Current
0363-0144	Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	Walgreen Company	ANDA	Current
0363-0144	Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	Walgreen Company	ANDA	Current
0536-1205	rugby mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Rugby Laboratories	ANDA	Current
11822-0144	mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Rite Aid Corporation	ANDA	Current
11822-0144	mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Rite Aid Corporation	ANDA	Current
30142-144	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Kroger Company	ANDA	Current
30142-144	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Kroger Company	ANDA	Current
30142-144	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Kroger Company	ANDA	Current
30142-144	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Kroger Company	ANDA	Current
36800-144	TopCare Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Topco Associates LLC	ANDA	Current
37808-446	Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	H E B	ANDA	Current
37808-446	Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	H E B	ANDA	Current
37808-777	mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	H E B	ANDA	Current
37808-777	mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	H E B	ANDA	Current
41250-144	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Meijer Distribution Inc	ANDA	Current
45802-230	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	Perrigo New York Inc	ANDA	Current
45802-230	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	Perrigo New York Inc	ANDA	Current
45802-230	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
46122-239	Good Neighbor Pharmacy Mucus D	Guaifenesin, pseudoephedrine hydrochloride	Amerisource Bergen	ANDA	Current
49035-729	equate mucus d	guaifenesin, pseudoephedrine hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49035-792	equate mucus d	guaifenesin, pseudoephedrine hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49348-113	Sunmark mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	McKesson	ANDA	Current
49348-113	Sunmark mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Strategic Sourcing Services LLC	ANDA	Current
49348-113	Sunmark mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Strategic Sourcing Services LLC	ANDA	Current
55316-144	healthy accents mucus relief D	Guaifenesin, pseudoephedrine hydrochloride	DZA Brands LLC	ANDA	Current
56062-144	Mucus D ER	Guaifenesin, pseudoephedrine hydrochloride	Publix Super Markets Inc	ANDA	Current
56062-144	Mucus D ER	Guaifenesin, pseudoephedrine hydrochloride	Publix Super Markets Inc	ANDA	Current
59779-825	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	CVS Pharmacy	ANDA	Current
59779-825	Mucus D	Guaifenesin, pseudoephedrine hydrochloride	CVS Pharmacy	ANDA	Current
62011-0259	Health Mart mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Strategic Sourcing Services LLC	ANDA	Current
62011-0259	Health Mart mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Strategic Sourcing Services LLC	ANDA	Current
62011-0259	Health Mart mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	McKesson	ANDA	Current
63187-960	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	Proficient Rx LP	ANDA	Current
63187-960	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	Proficient Rx LP	ANDA	Current
69256-144	Harris Teeter Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	Harris Teeter, LLC	ANDA	Current
69256-144	Harris Teeter Mucus Relief D	Guaifenesin, pseudoephedrine hydrochloride	Harris Teeter, LLC	ANDA	Current
70000-0004	leader mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Cardinal Health	ANDA	Current
70000-0004	leader mucus relief d	Guaifenesin, pseudoephedrine hydrochloride	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70518-0011	Guaifenesin and pseudoephedrine hydrochloride Extended Release	Guaifenesin, pseudoephedrine hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31514	ORIG	2015-06-02